MAUDE Adverse Event Report: LIFESCAN INC. 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.There is insufficient information to rule out the contribution of the subject meter to the event.
Additional Manufacturer Narrative
The reported issue has been investigated.Investigation concluded that the device performed as intended by displaying an error message, protecting the user from an erroneous result.Similar complaints for this issue were trended for the test strip lot.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.In addition, 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.

• Brand Name: OT ULTRA MINI METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN INC.; 20 valley stream pkwy; malvern PA 19355
• 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: 18482117
• Report Number: 3009698388-2024-00001
• Device Sequence Number: 9016711
• Product Code: NBW
• UDI-Device Identifier: 00353885008136
• UDI-Public: 00353885008136
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K061118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Male