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

Lot Number 5665500

Device Problems Battery Problem (2885); Power Problem (3010)

Patient Problem Hypoglycemia (1912)

Event Date 10/21/2023

Event Type  Injury  

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 Description

On (b)(6), 2023, a reporter for the lay user/patient contacted lifescan (lfs) united states, alleging that the patient¿s onetouch verio flex meter displayed the battery indicator symbol and powered off during use.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated on (b)(6), 2023, at 9:00 am, the patient started ¿passing out¿ and when they attempted to test the patient¿s blood glucose with the subject meter, they were unable to obtain any reading due to the reported issue.The patient is on insulin pump therapy.The reporter claimed they took action of treating the patient with glucose tablets at 10:00 am.The reporter advised that when the emergency medical services (ems) arrived at 10:20 am, the patient received a blood glucose result of "63 mg/dl" on the ems device.No additional treatment was reported.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 educated the reporter on the meter¿s behavior and auto-shutoff, however the alleged issue remained unresolved.The cca noted that based on the information provided, the subject meter¿s battery did not need to be replaced.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received third-party intervention for an acute low blood glucose excursion after they were unable to test their blood glucose due to the alleged power issue.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; 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: 18127661
• MDR Text Key: 327992705
• Report Number: 3008382007-2023-00061
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): N
• 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: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 5665500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2023
• 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): Required Intervention; Life Threatening