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

Model Number 023-271

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Dehydration (1807); Urinary Frequency (2275); Sleep Dysfunction (2517)

Event Date 11/16/2020

Event Type  Injury  

Event Description

On december 16, 2020, lay user/patient contacted lifescan (lfs) usa, alleging that their onetouch verioflex meter was testing in settings mode.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The patient reported that the alleged issue began 2 months prior to contacting lfs, around (b)(6) 2020.The patient manages his diabetes with self-adjusted insulin (unspecified type or dose) and reported that in response to the alleged inaccuracy issue, he began adjusting his insulin dose without knowing his blood glucose levels; basing his dosage on advice from his father.The patient reported that around a month later, approximately around (b)(6) 2020, he developed symptoms of feeling "dehydrated", that he was "going to the bathroom a lot" and had "poor sleep".The patient advised that he self-treated by administering 15-20 units of insulin (unspecified type).The patient denied testing his blood glucose on another device.At the time of troubleshooting, the cca educated the patient on the correct testing procedure and walked him through a retest; however, the issue remained unresolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event for an acute high blood glucose excursion after the alleged issue with the subject device began.

• 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: 11086342
• MDR Text Key: 224100288
• Report Number: 2939301-2020-02797
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• 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
• Device Lot Number: 4447813
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/16/2020
• 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
• Patient Age: 43 YR