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

Lot Number	5631107
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch ultra mini meter was displaying an ¿error 5¿ message.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and on additional information obtained after customer care (cc) reviewed the call recording.The patient alleged that the error message began to appear on (b)(6) 2023, at an unspecified time.The patient did not report how he manages his diabetes, nor whether he made any changes in response to the alleged issue.The cca noticed during the call, between 4:43 pm and 5:11 pm, that the patient was not okay and he claimed that his ¿hands were shaking¿.The patient stated that he called his doctor who asked him to test, however the patient was not able to do so due to the alleged issue.The patient did not report any medical treatment.At the time of troubleshooting, the cca noted the subject meter was not being used for the first time and the issue was resolved during troubleshooting.The cca established that the error message was caused by the patient¿s testing technique.No further action was taken.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.

• Brand Name: OT ULTRA MINI METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; dammstrasse 19; zug 6300 ; SZ 6300
• MDR Report Key: 18482089
• Report Number: 2939301-2024-00002
• Device Sequence Number: 9033609
• Product Code: NBW
• UDI-Device Identifier: 00353885008136
• UDI-Public: 00353885008136
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Lot Number: 5631107
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/15/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Male