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

Lot Number	4244250
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Codes	Sweating (2444); Shaking/Tremors (2515)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, the lay user/patient contacted lifescan usa alleging her one touch ultramini meter doesn't turn on.The complaint was classified based on customer service representative (csr) documentation.The patient reported that the alleged power issue first occurred approximately one to two weeks prior to contacting lfs, at an unspecified time.The patient informed the csr that she manages her diabetes with a combination of oral medication (metformin 1000 mg and glipizide 50 mg).The patient did not specify whether she made any changes to her normal diabetes management regimen as a result of the alleged power issue.At an unspecified date and time, after the alleged product issue occurred, the patient developed symptoms of ¿sweating and shaking¿.It was not reported if the patient received any treatment for the symptoms.At the time of troubleshooting, the customer service representative (csr) confirmed that the subject meter was not being used for the first time and there was no indication of misuse to the device.The patient used the correct test strips.However, the csr also noted that inserting the test strips as well as pushing the power button did turn the subject meter on.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 alleged product issue began.There is insufficient information to rule out the contribution of the subject meter to the event.

• 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: 8003743
• Report Number: 3008382007-2018-02978
• Device Sequence Number: 1386408
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 10/16/2018

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: 4244250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/16/2018
• Device Age: 38 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 10/25/2018
• 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