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

Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Codes	Dizziness (2194); Shaking/Tremors (2515)
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 displayed the battery indicator symbol.The complaint was classified based on the customer care advocate (cca) documentation.The patient reported that the meter displayed the battery indicator symbol at 11:45 am on (b)(6) 2018.The patient manages her diabetes with metformin and glipizide oral medication.She denied making any changes to her usual diabetes management routine after the battery symbol appeared.She stated that about 5 minutes later, she developed symptoms of ¿dizziness and shakiness¿.She denied receiving any treatment for her symptoms above and beyond the usual routine of diabetes care and management.At the time of troubleshooting, the cca documented that the meter was not being used for the first time.Based on the information provided, there had been no misuse of the meter.Also, based on the information provided, the meter¿s battery needed to be replaced.After changing the battery, the issue was resolved.This complaint is being reported because the patient reportedly developed symptoms that meet lfs¿ criteria for a serious injury adverse event, i.E.Dizziness and shakiness, after obtaining the battery indicator symbol on the meter.

• 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: 7845170
• Report Number: 3008382007-2018-02473
• Device Sequence Number: 13790792
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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): 08/24/2018

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/24/2018
• Device Age: 74 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/05/2018
• 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
• Patient Age: 68 YR