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 Problems Headache (1880); Memory Loss/Impairment (1958); Dizziness (2194)

Event Date 05/01/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the patient called lifescan (lfs) us alleging that they were getting error 2 and error 4 messages on their onetouch verio flex meter.The complaint was classified based on the customer care agent (cca) documentation.The patient stated that the alleged issue had been ongoing ¿since the beginning of may¿.A test performed during the call resulted in an error 4 message being displayed.The patient reported that they had experienced ¿memory loss, headache, light-headedness and dizziness¿ ¿since the beginning of may¿.They manage their diabetes with a combination of insulin and oral medication however, no further details regarding type(s) or dosage(s) were provided.The only action taken by the patient in response to the error 2 and error 4 messages was to call lfs for assistance.They did not receive any treatment for their symptoms nor did they report making any changes to their normal diabetes management.During troubleshooting, the cca determined that the storage and testing technique were correct and the patient confirmed that this was not the first time the product was used.A replacement device was sent to the patient.This complaint is being reported because the patient claims they were unable to test their blood glucose due to the reported issue and reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged issue began.The subject device could not be ruled out as a contributing factor.

• 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: 11869271
• MDR Text Key: 252194961
• Report Number: 2939301-2021-02868
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): Y
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• 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: 4642518
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening