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

Model Number 023-271

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Fatigue (1849); Palpitations (2467)

Event Type  Injury  

Event Description

On (b)(6) 2020, the lay-user/patient contacted lifescan (lfs) (b)(4), alleging that her onetouch verio flex meter read inaccurately high compared to another meter.The complaint was classified based on the customer service agent (csa) documentation.The patient reported that the alleged inaccuracy issue began one week prior to contacting lfs; exact date and time not reported.The patient claimed obtaining alleged inaccurate high readings with the subject meter using an "old vial of strips" compared to readings of ¿191 and 198 mg/dl¿ on another meter, performed within 30 minutes of each other.The exact results obtained on the subject meter with the "old vial of strips" were not reported.The patient stated that she manages her diabetes with victoza in the morning and toujeo insulin in the evening on a self-adjusted dose.The patient claimed she injected herself with "a lot of insulin" (44 units) in response to the alleged issue then developed symptoms of ¿heart beats fast and tiredness¿.The patient denied receiving medical treatment.At the time of troubleshooting, the csa confirmed the unit of measure was set correctly on the subject meter.The csa noted that an approved sample site was used for testing and that the correct testing process was being followed.The csa confirmed the test strip vial was intact and the test strips had been stored correctly and were not expired.The csa 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 signs/symptoms suggestive of a serious injury adverse event after taking insulin based on alleged inaccurate high results obtained with the subject meter.

Manufacturer Narrative

The lay user/patient¿s meter has been returned and evaluated by lifescan product analysis with the following findings: the meter has passed all testing with no faults found.The reported issue could not be confirmed.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 ; CH 6300
• MDR Report Key: 10006078
• MDR Text Key: 190059577
• Report Number: 3008382007-2020-03904
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): Y
• PMA/PMN Number: K150214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening