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

Model Number 023-271

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Dyspnea (1816)

Event Date 12/10/2021

Event Type  Injury  

Event Description

On december 13, 2021, a reporter for the lay user/patient contacted lifescan (lfs) united states, alleging that the patient¿s onetouch verio flex meter was displaying an ¿error 2¿ and ¿error 4¿ message.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that the alleged error messages began to appear on (b)(6) 2021.The patient manages his diabetes with metformin pills twice daily and insulin once daily.The reporter denied the patient made any changes to his usual diabetes management regimen due to the alleged meter issue.The reporter stated that 12 days after the alleged meter issue began, the patient developed symptom of ¿cannot breathe¿ and attended the emergency room (er) where his blood glucose measured ¿452 mg/dl¿ on the er meter.No additional treatment was specified.At the time of troubleshooting, the cca noted the subject meter was not being used for the first time.The cca walked through resolving the issue however the alleged issue remained unresolved.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged issue began.The subject meter could not be ruled out as a cause or contributor to the event.

Event Description

On december 13, 2021, a reporter for the lay user/patient contacted lifescan (lfs) united states, alleging that the patient¿s onetouch verio flex meter was displaying an ¿error 2¿ and ¿error 4¿ message.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that the alleged error messages began to appear on (b)(6) 2021.The patient manages his diabetes with metformin pills twice daily and insulin once daily.The reporter denied the patient made any changes to his usual diabetes management regimen due to the alleged meter issue.The reporter stated that 12 days after the alleged meter issue began, the patient developed symptom of ¿cannot breathe¿ and attended the emergency room (er) where his blood glucose measured ¿452 mg/dl¿ on the er meter.No additional treatment was specified.At the time of troubleshooting, the cca noted the subject meter was not being used for the first time.The cca walked through resolving the issue however the alleged issue remained unresolved.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged issue began.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; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 13023127
• MDR Text Key: 285330671
• Report Number: 2939301-2021-02996
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• 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: 4765160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Male