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

Lot Number 4730919

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Fatigue (1849); Vertigo (2134); Pallor (2468)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

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.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 reporter of the lay user/patient contacted lifescan (lfs) (b)(6), alleging that her mother¿s onetouch verio reflect meter was displaying the ¿error 2¿ message after applying a blood sample.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The reporter alleged that the error message began to appear on (b)(6) 2021, at 3 pm.The patient manages her diabetes with oral medication (metformin ¿ dose unspecified) and the reporter claimed that she did not make any changes to her usual diabetes management regimen in response to the alleged issue.The reporter stated that her mother got sick because she was unable to test and therefore developed symptoms of ¿dizziness, weakness and pale¿ between 3 and 4 pm, after the issue occurred.The reporter informed the cca that her mother was taken to the emergency room (er) where they obtained a blood glucose reading of ¿52 mg/dl¿ on a clinic meter.The reporter advised that her mother received hcp treatment, but she could not remember what kind of treatment.At the time of troubleshooting, the customer care agent (cca) noted the subject meter was not being used for the first time.The strips had not been open longer than the discard date, had not expired, and had been stored correctly.The patient had followed the correct testing process.The cca walked the patient through resolving the alleged issue however the issue remained unsolved.A replacement meter has been sent to the patient.This complaint is being reported because the patient claims she was unable to test her blood glucose due to the reported issue and reportedly developed symptoms suggestive of a serious injury adverse event after the alleged meter issue began.

• Brand Name: OT VERIO REFLECT 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: 12443580
• MDR Text Key: 273600678
• Report Number: 3008382007-2021-04225
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• PMA/PMN Number: K193475
• 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: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4730919
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2021
• 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; Required Intervention