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

Lot Number	4350284
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Syncope (1610); Dizziness (2194); Sweating (2444)
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 was reading inaccurately high compared to another, hospital, meter.The complaint was classified based on customer service representative (csr) documentation.The patient reported obtaining an alleged inaccurately high result with the subject meter, on (b)(6) 2018 at 7:00am, but she was unable to recall the exact result.The patient stated that she manages her diabetes with insulin ¿ self adjusted and in response to the alleged inaccurately high result, she reported taking an, ¿increased insulin intake¿ based on the results she obtained and how they related to a sliding scale.The patient reported that a few minutes later she developed symptoms of feeling, ¿dizziness, sweaty, about to faint¿.In response to the symptoms, the patient denied receiving any treatment over and above her usual diabetes management routine.The patient reported becoming aware of the alleged product issue when she obtained a result of, ¿345 mg/dl¿ with the subject meter and, ¿270 mg/dl¿ with the hospital meter.Meter to other meter comparisons do not reasonably suggest that a malfunction has occurred.There can be no presumption as to which meter¿s reading is erroneous as the comparison is not made to a calibrated reference method.During troubleshooting, the csr verified that the unit of measure was set correctly at the time of testing and the results obtained were taken from an approved sample site.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 taking an increased dose of insulin based on an alleged inaccurate high result obtained with the subject 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: 7972772
• Report Number: 3008382007-2018-02900
• Device Sequence Number: 1739147
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 10/12/2018

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: 4350284
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/12/2018
• Device Age: 43 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 10/17/2018
• 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