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

Model Number 023-271

Device Problem Device Handling Problem (3265)

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

Event Date 10/12/2021

Event Type  Injury  

Manufacturer Narrative

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) 2021, the lay-user/patient contacted lifescan (lfs) united states, alleging that her onetouch verio flex meter read inaccurately low compared to a hospital meter.The complaint was classified based on further information obtained by the medical surveillance specialist after reviewing the call recording, since the patient was unwilling to provide additional information during a follow-up call.During the call, the patient reported that the alleged meter inaccuracy occurred one week prior to contacting lfs.The patient reported obtaining a blood glucose reading of ¿42 mg/dl¿ with the subject meter compared to a reading ¿higher than 100 mg/dl¿ on a hospital meter, performed more than 30 minutes apart.The patient stated that she manages her diabetes with oral medication and denied making any changes to her usual diabetes management regimen as a result of the alleged issue.The patient reported developing symptoms of feeling ¿dizzy and disorientated¿ at the time of the alleged issue.In response to the symptoms, the patient claimed an ambulance was called for assistance and she was taken to hospital where her blood glucose measured ¿higher than 100 mg/dl¿ on the hospital meter.During the call, the patient claimed she received treatment in hospital to bring her blood glucose down but was unable to recall the exact treatment received.At the time of troubleshooting, the customer care agent (cca) confirmed the unit of measure was set correctly on the subject meter.The cca noted that an approved sample site was used for testing, the correct testing process was being followed and the test strips were stored correctly (per owner¿s booklet recommendation).The cca noted the patient did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event requiring medical intervention.The subject meter could not be ruled out as a cause or contributor to the event.

Manufacturer Narrative

The lay user/patient¿s meter and test strips have been returned and evaluated by lifescan product analysis with the following findings: the meter has passed performance testing with no faults found.The reported issue could not be confirmed.Further analysis was not possible for the returned test strips due to unknown storage and handling preventing the allegation being physically investigated.In addition, a device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• 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: 12775952
• MDR Text Key: 281198109
• Report Number: 3008382007-2021-04267
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• 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,Followup
• Report Date: 02/08/2022

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: 4753361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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; Required Intervention