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

Medical Device Problem Code	Failure to Back-Up (1047)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On august 6, 2024, the lay user/patient contacted lifescan (lfs) united states, alleging a meter memory issue with her onetouch verio flex meter.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained by the medical surveillance specialist after reviewing the call recording.The patient reported that she became aware of the alleged meter issue 2 weeks prior to contacting lfs.The patient reported that the results between (b)(6) 2024, and (b)(6) 2024, had been erased from the meter.The patient stated that she manages her diabetes with novolog insulin (before meals on a sliding scale based on blood glucose readings) and lantus insulin (set dose morning and night) and tests her blood glucose 4 times a day.The patient denied making any changes to her usual diabetes management regimen due to the alleged issue.The patient denied developing any symptoms as a result of the alleged issue, however reported being taken to the emergency room by her son on (b)(6) 2024, due to elevated readings.The patient stated she was treated with doses of novolog and lantus insulin according to their protocol to bring the numbers down and 1 dose of iv antibiotic.The patient claimed she was discharged from the hospital when she received a fasting blood glucose result of below 200 mg/dl.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 of the device.The cca walked the patient through resolving the issue, however the alleged issue could not be resolved.A replacement product was sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute high blood glucose excursion after the alleged issue began.The subject meter could not be ruled out as a cause or contributor to the event.
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.

• Brand Name: OT VERIO FLEX METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; dammstrasse 19; 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: 20005423
• Report Number: 3008382007-2024-00040
• Device Sequence Number: 4343515
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 08/20/2024
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown