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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT

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LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT Back to Search Results
Event Type  Death  
Manufacturer Narrative

Corrected data: the following is additional manufacturer narrative that was truncated from the initial supplemental 3500a report #1 transmitted on (b)(4) 2013: when the hcp/reporter was asked whether the technique for applying blood on the test strip was correct - the hcp/reporter responded that the testing technique was correct. When the hcp/reporter was asked whether the test strips were in good condition and not expired - the hcp/reporter responded that the test strips were in good condition and not expired. The cause of death reported by the hcp/reporter was "cardiac arrest due to hyperkalemia. " hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated. Extreme hyperkalemia is a medical emergency due to the risk of potentially fatal abnormal heart rhythms. Confirmed that in his medical professional opinion the meter, test strips, or control solution, associated with the complaint, were not directly responsible for the patient's death. The reporter indicated that a death certificate was not available at the time of the discussion. On (b)(4) 2012, lifescan requested that the meter, test strips, and control solution be returned for product analysis testing. Lifescan received the meter on (b)(4) 2013 and the meter was tested on (b)(4) 2013 and no faults were found with the meter. The complaint was not confirmed. On (b)(4) 2013, a review of the device history record (dhr) for the meter was completed which did not reveal any non-conformances, process or product deviations, or rework activity associated with the item. Lifescan has been unable to conduct any retain testing on test strips since the reporter was unable to provide the test strips lot number for the test strips used on (b)(4) 2012. No further information was provided. If lifescan obtains any additional information, lifescan will send a secondary supplemental report.

 
Manufacturer Narrative

Supplemental #1 (b)(4) 2013. Lifescan conducted six follow-up attempts, two on (b)(4) 2012, one on (b)(4) 2012, one on (b)(4) 2013, and two on (b)(4) 2013, to obtain additional information/clarification regarding this event from the healthcare professional/reporter. On (b)(6) 2013 in response to our requests for additional information, the healthcare professional/reporter provided the following information: confirmed that the patient came into the smur (similar to mobile intensive care unit) on (b)(6) 2012 due to hyperglycemia. Described the patient as having the following symptoms prior to the blood glucose testing on (b)(6) 2012: "confused, pale, sleepy. " reaffirmed that despite having requested it from the hcp/reporter (b)(6) 2013, no information was available regarding the patient's diabetes management regimen (i. E. Blood glucose monitoring system used, testing frequency, prescribed diabetes medications). Confirmed that the meter, test strips, and control solution associated with the complaint belonged to the hospital. Reaffirmed as reported in the initial manufacturer incident report form, results of 40 mg/dl on (b)(6) 2012 at 14:05, 126 mg/dl on december 16, 2012 at 14:05, 47 mg/dl on (b)(6) 2012 at 14:30, and 118 mg/dl on (b)(6) 2012 at 15:35 were obtained from the meter associated with the complaint. These results were for (b)(6) 2012. When the hcp/reporter was asked in what way were the lifescan products responsible - the hcp/reporter responded that "at the time the glycemia was done, if the meter could have displayed hi, we could have anticipated in acting (with insulin pump right away). ".

 
Manufacturer Narrative

Lifescan has performed additional investigation on the returned meter. Our investigation has revealed that when the onetouch verio pro meter measures a blood glucose less than or equal to 1023 mg/dl the meter will give an accurate result (numeric results for values between 20 and 600 mg/dl; low blood glucose for results less than 20 mg/dl; and "extreme high bg" for results greater than 600 mg/dl). However, when the blood glucose measurement is greater than 1023 mg/dl the result will be inaccurately low. The result that will appear on the screen and will be recorded in the memory will be the result minus 1024 mg/dl.

 
Event Description

An hcp contacted lifescan (lfs) (b)(6) 2012, alleging that a patient had died because of inaccurately low blood glucose results on the onetouch verio-pro meter. Lfs was unable to obtain follow up information from the hcp after six attempts. So, this medical surveillance specialist classified the complaint based on the initial call placed on (b)(6) 2012: the reporter mentioned on (b)(6) 2012, the patient had the following readings on the onetouch verio-pro meter: at 2:05pm, the patient's blood glucose was 40 mg/dl and their blood glucose was retested again with a result of 126 mg/dl, at 2:30 pm the result was 47 mg/dl and at 3:35pm the reading was 118 mg/dl. The patient's blood glucose was tested at the lab on (b)(6) 2012, at 3:54pm with a result of 1305 mg/dl. No further clinical information was provided. In particular, it would have been helpful to know what setting (hospital, clinic, home, etc. ) the patient was being tested when the patient got the low results, the patients symptoms and treatment for the low results and ultimately the result of 1305 mg/dl, and the patient's condition of health prior to and on (b)(6). It is also unknown what lead the patient to be tested at the laboratory. Finally, lfs was not provided information as to the cause of death as stated on the death certificate or events that lead up to the patient's death. Finally, there was no information about the condition of the test strips. Products were requested back for investigation. With a glucose greater than 1300, the patient was probably severely dehydrated, if not in shock, and in a hyperosmolar state (with or without ketosis). As the instructions for use note, severe dehydration, shock, and a hyperosmolar state may produce falsely low results. Although the exact cause of death for the patient is unclear, this case is being reported as an adverse event because an hcp reported that the patient obtained low results on the onetouch verio-pro meter and soon after had a laboratory blood glucose result of 1305 mg/dl. The hcp stated also that the low results lead to the patient's death.

 
Manufacturer Narrative

Lot # was not provided. Products were requested back for investigation.

 
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Brand NameOT VERIO PRO METER
Type of DeviceGLUCOSE MONITORING SYS/KIT
Manufacturer (Section F)
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
gubelstrasse 34
zug
SWITZERLAND 6300
Manufacturer (Section D)
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
gubelstrasse 34
zug
SWITZERLAND 6300
Manufacturer (Section G)
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
gubelstrasse 34
zug
SWITZERLAND 6300
Manufacturer Contact
m. chiusano / y. wandolski
gubelstrasse 34
zug  
SWITZERLAND   6300
Device Event Key2947703
MDR Report Key2923284
Event Key2819800
Report Number3008382007-2013-01078
Device Sequence Number1
Product CodeNBW
Report Source Manufacturer
Source Type User facility,Foreign
Reporter Occupation Other
Type of Report Followup,Followup
Report Date 12/24/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
OTHER Device ID Number1-12RK5WT
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/07/2013
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date12/24/2012
Device Age4 mo
Was The Report Sent To Manufacturer? No
Date Manufacturer Received12/24/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/16/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/22/2013 Patient Sequence Number: 1
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