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

Model Number 023-271

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Fatigue (1849); Paresis (1998); Shaking/Tremors (2515)

Event Date 12/28/2021

Event Type  Injury  

Manufacturer Narrative

Similar complaints for this issue were trended including the reported meter.It was concluded that the number of complaints for the meter did not breach thresholds indicative of a systemic issue.An evaluation of the test strip lot was unable to be conducted as the lot number was not provided.

Event Description

On december 29, 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch verio flex meter was reading inaccurately high compared to another meter.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and on information obtained after the cca reviewed the call recording.The patient alleged that the issue began at an unspecified time in the night of (b)(6) 2021, when he obtained a blood glucose result of ¿144 mg/dl¿ on the subject meter.The patient manages his diabetes with unspecified insulin (self-adjuster) and stated that he took 12 units of insulin in response to the reading of ¿144 mg/dl¿.When the patient woke up the next day early in the morning, he felt that his glucose was too low and started developing symptoms of ¿shaking, could not move and felt weak¿.The patient¿s wife helped him obtaining a blood glucose result on a ¿contour next¿ meter and the patient received a reading of ¿39 mg/dl.¿ the patient¿s wife gave him some candies and called 911.The patient claimed that he went to the emergency room and received unspecified hcp treatment.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter.The cca noted that the patient did not have control solution at the time of the call to test the subject system.A replacement meter has been sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after taking an increased dose of insulin based on alleged inaccurate high results obtained with the subject meter.

• 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
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; UK IV2 3ED ; 1463383679
• MDR Report Key: 13311502
• MDR Text Key: 286764486
• Report Number: 3008382007-2022-04287
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Male