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

Model Number 023-271

Device Problem Power Problem (3010)

Patient Problems Fatigue (1849); Hyperglycemia (1905)

Event Date 09/07/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay user/patient contacted lifescan (lfs) united states, alleging that their onetouch verio flex meter did not power on.The complaint was classified based on the customer care agent (cca) documentation.It was not reported when the alleged power issue began.The patient manages their diabetes with insulin (sliding scale).It was not reported what action the patient took regarding their usual diabetes management regimen when they were unable to measure their blood glucose due to the alleged issue.The patient reported that on (b)(6) 2022, after the alleged issue began, they developed symptom of feeling ¿tired¿ and attended the hospital for a pre-op examination where a blood glucose reading of ¿519 mg/dl¿ was obtained on the hospital meter.The patient was treated with insulin and hospitalized for 3 days.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 to the device.The cca noted the meter would power on manually when the power button was pressed and when a new test strip was inserted.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 meter issue began.The subject meter could not be ruled out as a cause or contributor to the event.

• 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
• MDR Report Key: 15459781
• MDR Text Key: 300300969
• Report Number: 2939301-2022-03100
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• 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: 4668483
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Female