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

Lot Number	4610510
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	07/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Similar complaints for this issue were trended including the reported meter.It was concluded that the number of complaints for the meter did not breach thresholds indicative of a systemic issue.
Event or Problem Description
On july 24, 2023, the lay user/patient contacted lifescan (lfs), alleging that her onetouch verio flex meter would not power on.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged power issue began 3 weeks prior to contacting lfs, and she was unable to test her blood glucose due to the reported issue.The patient manages her diabetes with oral medication (janumet 50/500 mg, 2 tablets daily).It was not reported if the patient made any changes to her usual diabetes management regimen as a result of the alleged issue.The patient reported that on (b)(6) 2023, she developed symptoms of feeling ¿lightheaded¿ and feeling ¿like falling down¿.The patient reported that she drank water and consumed candy as self-treatment for the symptoms.The patient denied using any other device to test her blood glucose.At the time of troubleshooting, the cca noted the subject meter was not being used for the first time and there was no indication of misuse.The cca noted the battery needed to be replaced, however the issue was not resolved after a new battery was installed.Replacement products were sent to the patient.This complaint is being reported because the patient claims she was unable to test her blood glucose due to the alleged power issue and reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged issue began.

• Brand Name: OT VERIO FLEX METER
• Common Device Name: 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: 17401818
• Report Number: 3008382007-2023-00041
• Device Sequence Number: 5962421
• Product Code: NBW
• UDI-Device Identifier: 00353885010719
• UDI-Public: 00353885010719
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2023

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
• Operator of Device: Lay User/Patient
• Device Lot Number: 4610510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown