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

Lot Number	4051873
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194); Shaking/Tremors (2515)
Date of Event	08/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(\6) 2018, the lay user/patient contacted lifescan (lfs), alleging that her onetouch ultra mini meter had a power issue - turns off during use.The complaint was classified based on the customer care advocate (cca) documentation.The patient reported that the alleged product issue began on (b)(6) 2018, 8:45am.The patient manages her diabetes with oral medications (metformin), diet and exercise.It is unclear if the patient made any change to her usual diabetes management routine in response to the alleged product issue.She stated that ¿a few minutes¿ after the alleged product issue began, she developed the symptoms of ¿dizzy, headache and shaky¿.The patient stated that she self-treated with food and drink.¿sweets¿.At the time of troubleshooting the cca noted that it was not the first time the meter was being used, there was no misuse of the meter.After educating the patient about the auto shut off, the issue remained unresolved and based on the information provided the battery did not require to be replaced.The patient¿s products were replaced.This complaint is being reported because the patient reportedly developed signs and/or symptoms that that meet lfs¿ criteria for a serious injury adverse event after the alleged product issue began.

• 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: 7804079
• Report Number: 3008382007-2018-02344
• Device Sequence Number: 13716339
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Lot Number: 4051873
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/17/2018
• Device Age: 35 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 08/22/2018
• 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: 69 YR
• Patient Weight: 47