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

Model Number 023-271

Device Problem Loss of Power (1475)

Patient Problems Loss of consciousness (2418); Ambulation Difficulties (2544); Syncope/Fainting (4411)

Event Date 01/20/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the patient called lifescan (lfs) us alleging that their onetouch verio flex meter would not power on when inserting a test strip.The complaint was classified based on the customer care agent (cca) documentation.The patient claimed that they had been experiencing the power issue since (b)(6) 2020, and alleged that, on the afternoon of (b)(6) 2021, they had difficulty walking and fainted due to not being able to test.The patient manages their diabetes with insulin (self-adjuster), humalog and lantus, no further details were specified.They were treated with food/drink (¿half a can of coke¿) but it¿s unclear if this was self-treatment or administered by someone else.The patient alleged that they had to have emt assistance but they had no information regarding any further treatment received due to fainting.The patient made no changes to their diabetes management routine.During troubleshooting, the patient confirmed that this was not the first time the product was used and that the meter powered on with the power button.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, they reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged issue began and reportedly received hcp treatment following this incident.

• 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: 11320641
• MDR Text Key: 231586246
• Report Number: 2939301-2021-02827
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention