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

Model Number 023-271

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Fatigue (1849); Dizziness (2194); Cognitive Changes (2551)

Event Date 06/17/2022

Event Type  Injury  

Manufacturer Narrative

The reported issue has been investigated.Investigation concluded that the device performed as intended by displaying an error message, protecting the user from an erroneous result.In addition, similar complaints for this issue were trended for the test strip lot.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.

Event Description

On june 22, 2022, the lay user/patient contacted lifescan (lfs), alleging that their onetouch verio flex meter was displaying an ¿error 2¿ message during testing.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged error message began to appear around (b)(6) 2022.The patient manages their diabetes with metformin medication and insulin on a self-adjusting dose.The patient claimed that as a result of the error message appearing, they were unable to measure their blood glucose and take action regarding their usual dose of insulin.The patient reported that 1 day after the alleged issue began, they started developing symptoms of feeling ¿tired, mind goes blank and dizzy¿.The patient reported taking a nap in order to feel better.At the time of troubleshooting, the cca noted the subject meter was not being used for the first time.The cca walked through resolving the issue however the alleged issue could not be resolved.Troubleshooting determined the issue to be a meter issue.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after they were unable to measure their blood glucose due to the alleged meter issue.

• Brand Name: OT VERIO FLEX METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; UK IV2 3ED ; 1463383679
• MDR Report Key: 14881525
• MDR Text Key: 295124392
• Report Number: 3008382007-2022-04320
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 023-271
• Device Catalogue Number: 023-271
• Device Lot Number: 4819867
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 06/30/2022
• 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