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 Problem Shaking/Tremors (2515)

Event Date 08/10/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the reporter of the lay user/patient contacted lifescan (lfs) usa, alleging that the patients onetouch verio flex meter was reverting to setup mode.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call, since the patient was unable to be reached by phone for follow-up questions.The reporter alleged that the power issue started on (b)(6) 2021, at an unspecified time.The reporter stated that when the patient turned on the subject meter it only displays the date blinking after she replaced the battery.The patient manages her diabetes with keeping in control of her diet and the reporter stated that the patient did not make any changes to her diabetes management regimen in response to the alleged issue.At an unspecified time after the issue occurred on (b)(6) 2021, the patient started to feel ¿shaky¿.During the call with lfs the patient was able to perform a test with the subject meter and stated that the result was ¿good¿.She did not specify the exact blood glucose reading.There was no report of any medical treatment/intervention received as a result of the alleged issue.At the time of troubleshooting, the customer care agent (cca) noted the subject meter was not being used for the first time and that there was no indication of misuse to the device.The cca educated the reporter on setting up the meter and the issue was resolved.The patient did not need a replacement meter after the issue was resolved.Medical surveillance was unable to reach the patient to clarify if she believed the device contributed to the adverse event.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after using the product.The subject meter could not be ruled out as a cause or contributor to the event.

Manufacturer Narrative

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 FLEX METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 12346034
• MDR Text Key: 267499496
• Report Number: 3008382007-2021-04213
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885010986
• UDI-Public: 00353885010986
• Combination Product (y/n): Y
• PMA/PMN Number: K150214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• 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: ZGMMD2SS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening