MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT VERIO 2 METER; GLUCOSE MONITORING SYS/KIT

Model Number 022-659

Device Problem Defective Component (2292)

Patient Problem Diaphoresis (2452)

Event Date 07/19/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the lay-user/patient contacted lifescan (lfs) usa, alleging that the meter was reverting to set-up mode after replacing the batter and the ¿ok button¿ on his onetouch verio2 meter was not working.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged issue started on (b)(6) 2021, around 7 or 8 pm after he replaced the batteries from the subject meter.The meter asked to confirm the date and time, but the patient was unable to select because the ¿ok button¿ did not work.The patient stated he was unable to test his blood glucose due to the alleged meter issue.The patient usually manages his diabetes with insulin (novolog ¿ dosage depends on meter readings) and did not report any changes made to his usual diabetes management regimen.The patient claimed he felt his glucose was low and started to develop the symptom of ¿sweating¿ around midnight.The patient informed the cca that he treated himself with two glucose tablets around midnight when he ¿felt bad¿.No other blood glucose readings were reported.At the time of troubleshooting, the cca noted that the patient did not use the subject meter for the first time and there was no indication of misuse to the device.Replacement products have been sent to the patient.This complaint is being reported because the patient claims he was unable to test his blood glucose due to the reported issue and reportedly developed symptoms suggestive of a serious injury adverse event after the alleged meter issue began.

Manufacturer Narrative

A device history record review could not be performed as the meter serial number was unavailable.This supplemental is being sent to include the investigation conclusion code that was omitted from the h6 field of the initial report.The investigation conclusion code that should have been included at the time of submission of the initial report is: 67.If lifescan obtains additional information regarding this complaint, a follow up report will be submitted.At this time, lifescan considers this matter closed.

• Brand Name: OT VERIO 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 12222151
• MDR Text Key: 263435454
• Report Number: 3008382007-2021-04194
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008730
• UDI-Public: 00353885008730
• Combination Product (y/n): Y
• PMA/PMN Number: K131363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022-659
• Device Lot Number: 4482773
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR