MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT ULTRAMINI METER; GLUCOSE MONITORING SYS/KIT

Lot Number	4380815
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	07/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultramini meter would not power on.The complaint was classified based on the customer care advocate (cca) documentation.The patient reported that despite a recent battery change, the meter would not power on at 3pm on (b)(6) 2018.The patient manages her diabetes with insulin pump therapy.She reported that as a result of the alleged issue, she was unable to test her blood glucose level.She indicated that at about 4pm on (b)(6) 2018, she became ¿shaky¿.She stated that at 6:30pm on (b)(6) 2018, she ate cheese to ¿relieve¿ her shakiness and felt better a short time later.No additional assistance was sought.At the time of troubleshooting, the cca noted that the meter was not being used for the first time.Based on the information provided there had been no misuse of the meter.The patient confirmed that she was using the correct test strips but the meter would not turn on when a new test strips was inserted per owner¿s manual or when the power button was pressed.Based on the information provided, the meter¿s battery did not need to be replaced.The issue could not be resolved with training.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed a symptom suggestive of a serious injury adverse event, i.E.Shaky, after the meter stopped powering on.

• Brand Name: OT ULTRAMINI METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7741842
• Report Number: 3008382007-2018-02192
• Device Sequence Number: 19468176
• Product Code: NBW
• UDI-Device Identifier: 00353885002684
• UDI-Public: 00353885002684
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 07/30/2018

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: 4380815
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/30/2018
• Device Age: 128 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Weight: 91