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

Lot Number	4526262
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Codes	Blurred Vision (2137); Dizziness (2194)
Date of Event	09/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a reporter for the patient (the patient¿s wife) contacted lifescan (lfs) usa, to report that the patient¿s onetouch ultramini meter would not turn on.The complaint was classified based on the customer care advocate (cca) documentation.The reporter stated that the meter stopped powering on, on (b)(6) 2019; she reported that she then bought batteries and inserted them into the meter, but still the meter would not turn on.The patient manages his diabetes with novolin insulin (no adjustments).The reporter denied that the patient made any changes to his usual diabetes management routine after the meter stopped powering on.She indicated that on (b)(6) 2019, the patient developed symptoms of ¿dizziness and blurry vision¿.She denied that the patient received any treatment for his symptoms above or beyond the usual routine of diabetes care and management.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 reporter confirmed that the patient was using correct onetouch ultra test strips.However, the meter did not turn on when the power button was pressed or when a test strip was inserted per owner¿s manual.The issue could not be resolved with training and remained unresolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event, after the meter stopped powering on and he had continued with his usual diabetes management routine.

• Brand Name: OT ULTRAMINI METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8968729
• Report Number: 3008382007-2019-03710
• Device Sequence Number: 13530754
• Product Code: NBW
• UDI-Device Identifier: 00353885011464
• UDI-Public: 00353885011464
• 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): 09/05/2019

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: 4526262
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/06/2019
• 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