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

Lot Number 4767533

Device Problem Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 11/27/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, lifescan (lfs) received notification that an unspecified onetouch meter was reading inaccurately low.The complaint was classified based on the customer care agent (cca) documentation since the reporter could not be contacted for additional information.The reporter stated that the alleged meter issue occurred on (b)(6) 2021.The reporter claimed the subject meter displayed a warning message of ¿below 1.1 mmol/l¿ when testing on a patient, but the patient was hospitalized with ¿hyperglycemia symptoms¿.In response to the meter message, the reporter claimed the nurse gave the patient iv glucose (40 ml 50% glucose) as instructed.The reporter claimed that 15 minutes later, the nurse retested the patient¿s blood glucose with the subject meter however the issue reportedly still existed.The reporter stated that an arterial blood gas analysis was then performed by doctor¿s request and the patient¿s blood glucose measured ¿20.1 mmol/l¿.A retest was then performed with the subject meter using test strips from another vial and the patient¿s blood glucose measured ¿19.8 mmol/l¿.No further treatment was specified.Troubleshooting was unable to be performed.This complaint is being reported because the patient reportedly was administered iv glucose based on an alleged inaccurate low reading obtained on the subject meter which could have contributed to the reported hyperglycemia for which they were hospitalized.

• Brand Name: OT VERIO TEST STRIP
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 13183676
• MDR Text Key: 283817183
• Report Number: 2939301-2022-03004
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/06/2022

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 Expiration Date: 03/31/2023
• Device Lot Number: 4767533
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 68 YR
• Patient Sex: Male