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

Lot Number	4155676
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	Fainting (1847)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, the patient contacted lifescan (lfs) alleging that his onetouch ultra mini meter was reading inaccurately high compared to another meter (paramedics meter).The complaint was classified based on the customer care advocate (cca) documentation and additional information obtained when medical surveillance specialist (mss) made a follow up call.The patient stated that the issue first occurred on (b)(6) 2018, time unknown.The patient detailed that he tested his blood and obtained an alleged glucose result of 40mg/dl on the subject meter compared to 29mg/dl on the other 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.The patient stated that he manages his diabetes insulin (non-adjuster) and made no change to his usual diabetes management routine in response to the alleged product issue.The patient detailed to mss that on an unspecified time after the alleged issue began he had become ¿unconscious¿ and received hcp treatment of iv glucose from the paramedics.At the time of trouble shooting, the cca confirmed that the subject meter was set to the correct unit of measure, the sample was taken from an approved sample site and the correct testing steps were used.The test strips were stored correctly and within expiry date and the test strip vial was neither cracked nor broken.The patient did not have control solution to perform a test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs and/or symptoms 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: 7298624
• Report Number: 3008382007-2018-00642
• Device Sequence Number: 877381
• Product Code: NBW
• UDI-Device Identifier: 00353885002684
• UDI-Public: 00353885002684
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 02/22/2018

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: 4155676
• Other Device ID Number: 1-AGJ5R2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/22/2018
• Device Age: 22 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 02/27/2018
• 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