Summary of MedSun Reports Describing Adverse Events With Point-of-Care (POC) Glucose Meters
MedSun: Newsletter #40, September 2009

By Ahmed Haque, Patient Safety Staff, 2009

Point-of-Care (POC) glucose meters are medical devices intended to approximately evaluate the glucose concentrations found in blood. These devices are intensively used by patients with diabetes mellitus, who must carefully monitor their glucose readings to prevent entering hyperglycemia or hypoglycemia. Unlike their laboratory counterparts, POC meters can rapidly deliver results, often within seconds. Whole blood samples are obtained by pricking the skin with a lancet and then placing the resulting drop on a disposable strip. The various reagents, found in the strip and device, react with the glucose allowing a measurement to be made. Some meters measure the amount of electricity that can pass through sample; others measure how much light reflects from it. These measurements can then be converted into a digital output of glucose concentration (1,2).

Over the past five years, MedSun has received 24 adverse event reports associated with POC blood glucose meters. The reports represent seven manufacturers: Roche Diagnostics (14), Lifescan Inc (5), Abbott Diabetes Care Inc (3), Medtronic Minimed (1), and Becton Dickinson (1). These reports were submitted between January, 2004 and July, 2009.

The reported device problems include:

• Discrepancy with lab result (14)
• Inconsistent results using same device (3)
• Missing/defective device components (3)
• Defective strips (1)
• Time stamp error (1)
• Needle break (1)
• Test control solution fails quality control (1)
• Barcode identification error (1)
• Device failure after being dropped (1)

During this time period there were no reported deaths associated with these devices. Hospitalizations due to incorrect readings were reportedly required in two of the events. In 10 of the reports, clinicians found the reading of the device to be too high; in 4 of the reports they found the readings to be too low. There were also 2 reports of needle related injuries involved with the finger prick.

Of the reports that listed patient age, 2 listed patients aged 21 and younger and 17 listed patients aged over 21. Of the reports that listed gender, 14 involved female patients and 6 involved male patients.

These MedSun reports contributed to FDA awareness of the device problems. FDA follow-up with the manufacturer may have contributed to the following recalls.

Recall Information
Recall NumberTrade Name/Product Recall Class Date Intiated Date Posted Recalling Manufacturer Reason for Recall
Z-1070-2009 OneTouch SureStep Test Strips 2 11/25/2008 3/17/2009 Lifescan Inc Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.
Z-1317-2008 OneTouch Data Management Software v1.0 3 12/18/2007 4/8/2008 Lifescan Inc Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.
Z-0112-2008 Multiple brand names including: Precision Xtra 2 8/2/2007 2/14/2008 Abbott Diabetes Care Inc. Damage could lead to no display. Meters manufactured after January 31 2007 could exhibit meter display damage if dropped on a hard surface. These meters could exhibit unreadable lot number fields and date/time fields in addition to complete blanking of the numerical reading portion of the display.
Z-0458-2008 Advance Micro-draw Blood Glucose Monitoring System 3 10/18/2007 12/13/2007 ARKRAY USA INC. Mislabeled/coded strips : Meter kits from this lot contain mislabeled 10-count test strip vials. The code number printed on the Advance Micro-draw 10-count test strip bottle is incorrect. The code number on the vial is 867 when it should be 687. The 687-labeled code chip contains the correct calibration information for the 867 test strips so the meter will function properly and give accurate
Z-0264-2007 One Touch Ultra 1 11/1/2006 12/29/2006 Royal Global Wholesale Counterfeit Glucose Test Strips
Z-0265-2007 One Touch Basic/Profile 1 11/1/2006 12/29/2006 Royal Global Wholesale Counterfeit Glucose Test Strips (manufacturer unknown)
Z-1307-06 FreeStyle Flash 2 5/22/2006 8/3/2006 Abbott Diabetes Care Inc. The products may encounter display problem 'Er 4' message during prolonged use when the low battery symbol is displayed. The situation can render the meter either inoperable or operable with invalid user configuration data including selectable unit of measure and strip calibration code.
Z-1306-06 FreeStyle 2 5/22/2006 8/3/2006 Abbott Diabetes Care Inc. The products may encounter display problem 'Er 4' message during prolonged use when the low battery symbol is displayed. The situation can render the meter either inoperable or operable with invalid user configuration data including selectable unit of measure and strip calibration code.
Z-0887-05 LifeScan 2 11/17/2003 6/14/2005 Lifescan Inc A Control Solution range for the OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL.
Z-0821-05 LifeScan 1 4/11/2005 5/17/2005 Lifescan Inc User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
Z-0822-05 LifeScan 1 4/11/2005 5/17/2005 Lifescan Inc User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
Z-0823-05 LifeScan 1 4/11/2005 5/17/2005 Lifescan Inc User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
Z-0276-04 Hypoguard Advance 2 11/26/2003 12/25/2003 Hypoguard USA Inc. When actual blood glucose levels are in the low end of the blood glucose range the recalled test strips may provide inaccurately high readings.



Other recalls of interest include:

Other Recalls of Interest
Recall NumberTrade Name/Product Recall Class Date Posted Date Initiated Recalling Manufacturer Reason for Recall
Z-1356-06 ACCU-CHEK Advantage 2 6/22/2006 8/5/2006 Roche Diagnostics Corp. The meter gives an error message that can actually mean either a problem with the strip or a blood glucose too low to measure but the meter error message only reports that there is a strip error.
Z-1357-06 ACCU-CHEK Advantage 2 6/22/2006 8/5/2006 Roche Diagnostics Corp. The meter gives an error message that can actually mean either a problem with the strip or a blood glucose too low to measure but the meter error message only reports that the test strip may be damaged or test was not performed correctly.
Z-1366-06 AccuData GTS 2 6/22/2006 8/5/2006 Roche Diagnostics Corp. The meter gives an error message that can actually mean either a problem with the strip or a blood glucose too low to measure but the meter error message only reports that there is a bad strip.
Z-1370-06 ACCU-Chek Voicemate 2 6/22/2006 8/5/2006 Roche Diagnostics Corp. The meter gives an error message that can actually mean either a problem with the strip or a blood glucose too low to measure but the meter error message only reports that there is a bad strip.
Z-1371-06 ACCU-CHEK Voicemate 2 6/22/2006 8/5/2006 Roche Diagnostics Corp. The meter gives an error message that can actually mean either a problem with the strip or a blood glucose too low to measure but the meter error message only reports that there is a bad strip.
Z-1354-06 ACCU-CHEK Advantage 2 6/22/2006 8/5/2006 Roche Diagnostics Corp. The meter gives a strip error message that can actually mean either a problem with the strip or a blood glucose too low to measure but the meter error message only reports that there is a strip error and the manual only instructs the user to retest with a new strip using a larger drop of blood.
Z-0272-06 OneTouch Ultra 3 10/10/2005 12/8/2005 Lifescan Inc Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters




The following table lists the MedSun reports that are described in the device problem summary above.

[Note: The reports have been edited for clarity]

Adverse Events
DeviceDevice Identifiers Event Description
Roche Diagnostics: Accucheck None provided Accucheck test that was performed read "HI." The doctor was notified and orders of 10 units of regular insulin were given. At this point, results from serum glucose test done by lab (prior to insulin administration) shows glucose levels of 253. Doctor was notified of variance and a second accucheck test was performed (35 minutes post insulin administration). Result showed 161. Accucheck equipment was then replaced at that time. Throughout, patient remained alert, oriented, pink, warm and dry
Lifescan, Inc: Sure Step Pro Catalog: 010-797 / Lot: 2860185 008 Defective strips were noted to have a black band on the same side of the test strip as the pink application square. Reporter notes that "a black band should not be present on that side of the test strip." Test pads on the detective test strips seemed to have been missing or very loosely attached. Confirmation dot on the back of the test strip may also have been off center. The manufacturer Lifescan was notified and acknowledged the problem.
Roche Diag: Accucheck Inform None provided Patient arrived to the ED via wheelchair with a family member. He was triaged with an initial complaint of a sore throat, nausea, and vomiting for a couple of days. After triage, the patient was sent to the waiting room. The nurse went to the waiting room to bring the patient back. They found the patient lying on the floor of the waiting room, lethargic but arousable. Patient noted that he wasn't feeling well. An initial blood glucose check was done (using the Accucheck device) and controls were completed. According to the device, the blood glucose check read "too low to register" and the test was repeated. Again the check read "too low to register." The physicians were informed of the results. Two ampoules of dextrose 5% were ordered and given. IV fluids of dextrose 5% were also ordered and given. Approximately 35 minutes later, the lab reported and documented that the patient's serum glucose result (prior to dextrose) was 1284. The doctor was informed and new orders for an insulin drip were given instead. IV fluid was changed to normal saline. Another blood glucose check (cannot confirm by which device) was done which registered that "results were too high." In the blood glucose history, the control reading and the high reading were present. However, the two low readings were not shown. Patient was ultimately admitted to the ICU, diagnosed as a new diabetic, and discharged six days later.
Roche Diag: Accucheck Inform None provided Nursing dropped the glucometer resulting in a break. Glucometer was taped together with scotch tape and ran for patient results. Nurse obtained a critical value and treated patient with insulin. There was no documentation of controls being performed after the meter was broken. At change of shift, the new nurse noted patient was cold and unresponsive. Patient had a blood sugar of 15. Other patients were tested with the broken device, but values obtained were within normal ranges. These patients were ultimately retested by oncoming shift with a different meter.
Roche Diag: Accudata GTS Lot: 3B3A09 A glucometer seemed to have reported the wrong value. On first reading value reported was high, second was 474. Patient was given 12 units of regular insulin. An hour later, the patient became very ill and the dexi was checked with the [same] glucometer. Result given was 395. Blood was drawn and sent at the same time to the lab. Lab reported a value of 5. the patient was treated to increase blood sugar. The patient's blood sugar was checked by a second machine and the result was 333. Again blood was simultaneously sent [to the lab], which reported a value of 217. Patient's condition worsened and was transferred to the IMC [intermediate care unit]. Both glucose machines showed a discrepancy between the lab value of the patient's blood glucose. After patient received a bath a dexi strip was checked and revealed a blood sugar of 474. Patient was treated with 12 units of regular insulin.
LifeScan, Inc: One Touch Glucose Control Solution Lot: 3B3A09 The test control solution repeatedly failed quality control test on the sure step glucose monitor. Staff was able to complete quality control test with a high test control substance from a different lot number. Event was reported to internal supply chain manager for follow up.
Medtronic Minimed: Glucose Sensor Catalog: MMT-7002 / Lot: F133 A patient was admitted with hyperkalemia and hyperglycemia related to their diabetes. The physician ordered 24 hour glucose monitoring. When the diabetic educator was inserting the glucose sensor into the abdomen and then tried to pull the needle out, the handle came off, and the needle stayed over the sensor inside the skin of the abdomen. The needle separated from the injector. Thus, the needle holder broke in two pieces after being inserted into the patient's abdomen. The sensor and broken needle were removed. A new needle was inserted without incident. The patient had to be stuck twice.
Abbott Laboratories: Precision PCX None provided Blood was drawn from a patient in the morning and sent to the laboratory for a glucose reading. The same glucose meter was used to test the patients glucose levels at approximately an hour later. The time on the meter read approximately three hours ahead of time. When the physician received the results, the results indicated that the glucose levels had gone down (due to the incorrect time reading on the meter) when in reality the results had gone up. In this incident the patient was not harmed, but the potential existed for the misadministration of medication based on an incorrect meter time. Further follow up revealed that the meter clock stops when the meter is turned off. When the meter is turned on, the clock starts again thereby giving the test record a time stamp that is wrong. When the test record is uploaded to the hospital electronic medical record, the computer does not know that the time stamp is incorrect. It will sort all test records by date/time. When the physician reviews/compares bedside glucose test records with other meter records and lab records, it gives a false picture of the patient's response to treatment. The meter will regain the correct date/time from the hospital network when it is uploaded. however, experience has shown that the meter will lose the correct date/time again. Other causes are from the meter being dropped, bumped, etc. The meter date/time cannot be manually reset by the user. Biomed is not allowed to work with the meters. When there are problems, the vendor replaces them.
LifeScan, Inc: One Touch Sure Step Pro Lot: 261567A008 Nurse discovered that the blood oval on a surestep pro blood glucose test strip was "off center" on the strip. Additionally, the tip of the strip is offset. this prevents accurate measurement when inserted into the surestep blood glucose monitor. No harm to patient was noted. All products were returned and the defective lots were replaced by the company representative.
Roche Diag: Inform None provided A patient with a history of diabetes, cardiac ejection fraction of 5%, severe peripheral edema. The blood sugar was drawn and sent to lab. The accucheck was done and the result was 486 it was repeated and the result was 338. Sliding scale insulin was given (9units). The lab results were called to floor and the results were 30. The patient went into respiratory arrest & was intubated. Three hours later the accucheck was 70, a venous blood sugar was 12. The same meter displayed results of 104 & 157 from finger stick, 137 from earlobe, and a lab result of 116 & 117. Lab QA person checked the equipment to verify correct function of the device. The lab reports a similar occurrence where a patient who was on 21 different medications had finger stick results that did not correlate with the lab results, example: the finger stick was 570, and the lab draw was 169 40 minutes later. This was reported to Roche.
Roche Diag: Inform None provided This hospital uses the roche accu-chek inform glucometer that can read bar codes to identify the patient. The use of the bar code technology began in June, 2005. It is possible to scan bar codes other than the patient's armband ID and activate the glucometer. Staff has scanned other facility armbands, discharged patient chart labels (causes billing error leading to our discovery of the problem) and the room mates in semi-private rooms were mixed up as well. This problem has been seen in several of our sister system hospitals. The issue most often is related to isolation patients when the staff does not want to take any more equipment than necessary into the room and contaminate it. The staff will scan a "remote" bar code on another document and then enter the patient's room. This is not positive identification of a patient. The possibility is strong that a patient will either receive incorrect insulin (not their test result) or will not get the insulin they need thereby compromising either patient's condition. An engineering control could be easily placed in the glucometer software to help correct the inaccurate scanning. The staff tends to scan the "remote" document as the order of the setup process does not make the patient's id the last thing to complete before doing the test. Current process is the staff must first enter the patient id by scanning the bar code then scan the test strip. If this order was reversed, the test strips could be left out of the isolation room but be scanned (bar code on the container, not the strip) and the staff could then id the patient's armband bar code at the bedside. This would be a safer practice. The company has resisted making this change.
Becton Dickinson: Vacutainer Safety Lok Lot: 5A2561 A student was attempting to place shield over needle prior to discarding and found it to be more difficult than normal. Follow up reveals that the student sustained needle stick and required testing (in addition to the patient). A contributing factor was that the student got distracted when performing task. Other staff agree that the shield process is difficult on some of the needles.
Roche Diag Lot: 548521 Accucheck results not within acceptable range of disparity. Patient was a female admitted for respiratory failure, with a history of rheumatoid arthritis, peripheral vascular disease, osteoporosis, coronary artery disease, hypertension, developed a fungal uti. An accucheck was 384, with a second meter 182, minutes later reading was 328, and then within a few more minutes 266. Unable to verify with serum glucose due to poor access.
Roche Diag None provided This was a glucometer readings discrepancy. Finger stick readings read -hi out of normal, minutes later 138 and then within minutes 57. Less than a week later, a reading of 521 was noted, and then a few minutes later -111 was noted , and then a few minutes later 111 again.
Roche Daiag: Accucheck None provided Accucheck done with results of 382, rechecked a few minutes later showed 197, serum specimen drawn approximately 30 minutes later gave 77.
Roche Diag: Accucheck None provided Patient's glucose reads 394 mg/dl and insulin was given (18 units reg iv). Attempted to get a second reading and glucometer showed an error code. A second glucometer showed patient's glucose at 101 mg/dl. Dextrose 50% was given to counteract the insulin. The first glucometer was immediately shipped to the manufacturer without biomed investigating. A new unit was sent in by the manufacturer.
Abbot Lab: Medisense Precision PCX None Provided Facility has utilized medisense precision pcx strips for point of care glucose testing for many years. NiICU was plagued with requests from the term nurseries, and labor and delivery to retest infant's blood sugars using our i-stat device. The i-stat results were almost always significantly higher than the pcx readings. A few months ago we began using medisense precision pcx plus strips (aka: gold strips). The result was approximately a 75% drop in the number of i-stat tests being done in the NICU.
LifeScan Inc: Surestep Flex L6132SB00012 The nurse took the fasting blood sugar at 1700 and the result was 247. Patient was treated with 5 units of regular insulin. About 15 minutes after the administration: patient's husband stated that she was having hypoglycemic reaction. Nurse re-checked the blood sugar and found it was 259. The physician and nurse practitioner came right away and determined that patient may be experiencing a stroke. The stroke team was called. The blood sugar was re-checked again and found to be 12. Two glucometers were used that registered the high blood sugars. Both were pulled from service and sent to the laboratory for repair. Replacements were sent to the patient care unit. Investigations as follows: 1. nurse technique appropriate. 2. question of whether the new cleaning procedure for glucose machines may be altering results. Trial is in progress. 3. patient may have had a simple insulin reaction. patient is doing well and has been discharged.
Roche Diag Lot: UJ85002102 Discrepancies in 2 glucose readings done within minutes of each other. Compared with venipuncture glucose reading. Venipuncture value was used for treatment.
Roche Diag: Accucheck Lot: UJ35012137 Blood glucose on accu-chek results: 166 results from lab: 259. Both tests were run on same blood sample. Accu-chek controls completed and no problems were identified.
LifeScan Inc: Suretep Flex None provided Glucometer read 32. After sample was rechecked with another glucometer, the sample was 168. Patient was asymptomatic. The glucometer was sent to the laboratory that oversees the maintenance.
Roche Diag: Accucheck Inform System UJ82002422 Patient arrived to emergency room unresponsive. Accucheck glucose monitor showed a value of 93. Saline lock started and blood drawn for lab. Lab blood sugar 32. Emergency room staff concerned about difference in blood sugar results. Lab's point-of-care coordinator sent accucheck inform monitor to Roche to be checked out. lab's point-of-care coordinator feels difference can be explained by the emergency room finger stick being a capillary draw, while lab result from blood drawn from a saline lock.
Roche Diag: Accucheck Inform Monitor Catalog: 2001201 / Lot: UJ48020502 Reporter states connector pins on meter were missing while using the inform system. Reporter states the 3rd and 4th prong were missing from the right hand side. CI investigation confirmed melting/burning of pins 3 and 4. No adverse event was reported. A request was made for return of the suspect product and a replacement was sent.
Abbott Labs: Medisense Precision XTRA None provided EMS experienced an error with a precision extra glucometer device. The ambulance crew had responded to a call at another facility for a patient with an altered level of consciousness. On their arrival the facility staff reported an initial blood glucose reading in the 40s. This facility staff had administered oral glucose and im glucagon prior to the ambulance arriving, with a recheck blood glucose reading in the 50s. The ambulance crew checked the patient's blood glucose level twice with their device and received readings of 208 and 192 respectively. The patient was transported to the hospital ED and remained unresponsive. After the call was completed it was reported to the EMS supervisor that this patient's labs showed a blood glucose level of 20 (per the hospital lab). The patient was admitted to the ICU for observation, then discharged the next day. The glucometer was immediately pulled from service, and returned to the manufacturer.
Varta Microbattery: Easy Pack Battery (for glucose meter) Lot: 66380 712 099 This event occurred while replacing a battery in the glucose meter. While a charged battery was being placed into meter, the battery started to smoke and popped out of the meter. The battery then turned black and continued smoldering and smoking. Upon investigation, the battery was found to have burned a hole in the counter. There was no patient harm as a result, but the employee reported being bothered by the smoke from the burning battery. However, upon evaluation, no injury was identified. All batteries from this same manufacturer with the same date were removed and replaced. The manufacturer requested return of battery, meter, and docking station for analysis, and are currently pending investigation



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Other FDA articles and notices of interest related to these POC glucose meters include:

Overview: Glucose Testing Devices
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/GlucoseTestingDevices/default.htm

Consumer Update: Getting Up to Date on Glucose Meters
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049051.htm

Safety Tip: Blood Glucose Meters: Getting the Most Out of Your Meter
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109371.htm

Safety Tip: Useful Tips to Increase Accuracy and Reduce Errors in Test Results from Glucose Meters
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109519.htm

Safety Tip: Common Problems with the Use of Glucose Meters
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109449.htm

Safety Tip: Notes on Alternative Site Testing
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm070215.pdf

Safety Alert (for laboratories and clinicians): Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm155099.htm

National Diabetes Information Clearinghouse (National Institutes of Health)
http://diabetes.niddk.nih.gov/treatments/index.htm

Additional Information:

1. Lab Tests Online: Glucose
http://www.labtestsonline.org/understanding/analytes/glucose/glance.html

2. Glucose Testing Devices
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/GlucoseTestingDevices/default.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun