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

Model Number 023-271

Device Problem Failure to Calibrate (2440)

Patient Problems Dizziness (2194); Malaise (2359); Confusion/ Disorientation (2553)

Event Date 12/07/2022

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.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.

Event Description

On (b)(6) 2022, the lay user/patient contacted lifescan (lfs) united states, alleging that their onetouch verio flex meter would not power on when inserting a test strip.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged power issue began on (b)(6) 2022.The patient manages their diabetes with a fixed dose of insulin.The patient claimed they skipped food on the morning of (b)(6) 2022, when they were unable to perform a blood glucose test due to the reported issue.As a result, the patient experienced symptoms of ¿not feeling well, dizzy and confusion¿.There was no report of medical treatment/intervention received due to the alleged issue.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 correct test strips were being used for testing and based on the information provided, the battery did not need replaced.The cca confirmed the patient was able to turn the meter on manually when the power button was pressed.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after they were unable to test their blood glucose due to the alleged power issue.

• 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
• 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: 15964959
• MDR Text Key: 305335493
• Report Number: 3008382007-2022-04360
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 20353885010980
• UDI-Public: 00353885010986
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/12/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 023-271
• Device Catalogue Number: 023-271
• Device Lot Number: 4838910
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/12/2022
• 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): Life Threatening