MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT VERIO IQ METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4387477

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Twitching (2172)

Event Date 02/26/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, the lay user/patient contacted lifescan (lfs) united kingdom, alleging that her onetouch verioiq meter read inaccurately high compared to another meter.The complaint was classified based on the customer service representative (csr) documentation.The patient reported that the alleged meter inaccuracy began on (b)(6) 2019 at 4:00 pm.The patient obtained an alleged inaccurate high blood glucose reading of ¿8.3 mmol/l¿ with the subject meter compared to a reading of ¿5.6 mmol/l¿ with a ¿caresens¿ meter, within 30 minutes of each other.Meter to other meter comparisons do not reasonably suggest that a malfunction has occurred.There can be no presumption as to which meter¿s reading is erroneous as the comparison is not made to a calibrated reference method.The patient informed the csr that she manages her diabetes with insulin (self-adjuster) and claims that around 30 minutes later she performed another test on unspecified meter and obtained an unspecified result.The patient reported that at that time she started feeling like she was having a ¿hypo¿ with symptoms as ¿shaky and twitchy¿.She self-treated with 150 ml lucozade, which brought her blood sugar back to ¿around 6 mmol/l¿ (result obtained on an unspecified meter).During troubleshooting, the csr confirmed that the patient¿s meter was set to the correct unit of measure and an approved sample site was used to obtain the blood sample.The patient followed the correct testing process and the test strips had not been open longer than the discard date, had not expired, and had been stored correctly.The test strip vial was not cracked or broken.The csr noted that the patient did not have a control solution available to perform a quality control test.Replacement products have been sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after the alleged product issue began.There is insufficient information to rule out the contribution of the subject meter to the event.

• Brand Name: OT VERIO IQ METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: oyinkan donaldson ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8402811
• MDR Text Key: 138211655
• Report Number: 3008382007-2019-00643
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• PMA/PMN Number: K110637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4387477
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/05/2019
• Date Manufacturer Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Weight: 58