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

Lot Number	5813216
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	10/23/2024
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.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.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.
Event or Problem Description
On (b)(6) 2024, a reporter for the lay user/patient contacted lifescan (lfs) united states, alleging that the patient¿s onetouch verio flex meter was displaying an ¿error 5¿ message during testing.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that on (b)(6) 2024, between 6:00 pm and 6:30 pm, the patient was feeling ¿loopy¿.The patient drank orange juice and ate peanut butter then attempted to test her blood glucose at 6:30 pm but the alleged error message began prompting.The emergency medical services (ems) were reportedly notified for assistance.The reporter claimed that when ems arrived at 7:00 pm, they tested the patient¿s blood glucose on the ems meter and obtained a reading of ¿42 mg/dl¿ and treated her with intravenous fluids.At the time of troubleshooting, the cca noted that the subject meter was not being used for the first time.The cca walked through resolving issue and the alleged issue was resolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute low blood glucose excursion after the alleged meter issue began.The subject meter could not be ruled out as a contributor to the event.

• 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: 20593768
• Report Number: 3008382007-2024-00051
• Device Sequence Number: 15645871
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (Y/N): N
• 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): 11/01/2024

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
• Device Lot Number: 5813216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/01/2024
• 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
• Patient Sex: Unknown