BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2905799 · Received January 9, 2013

    Report

    Report Number
    3008382007-2013-00555
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 3, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER WAS DISPLAYING INACCURATELY HIGH RESULTS COMPARED TO AN EMERGENCY MEDICAL SERVICES (EMS) METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2012 AT 5PM. THE PATIENT REPORTED, HE OBTAINED A READING OF "214MG/DL" ON THE LFS METER. THE PATIENT REPORTED ON (B)(6) 2012 HE SELF ADMINISTERED 2 UNITS OF HUMALOG INSULIN IN RESPONSE TO THE READING. THE PATIENT REPORTED AT AN UNKNOWN TIME LATER, HE WAS "UNCONSCIOUS." THE PATIENT REPORTED ON (B)(6) 2012 EMS WAS CALLED AND AN UNKNOWN READING WAS OBTAINED ON AN EMS METER, AND THE PATIENT WAS TREATED WITH IV GLUCOSE. IT IS UNKNOWN IF THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING. THE PATIENT WAS USING AN APPROVED SAMPLE SITE TO OBTAIN THE SAMPLES. THE PATIENT'S TESTING PROCESS WAS CORRECT. THE PATIENT'S TEST STRIPS AND TEST STRIP VIAL WERE FOUND TO BE IN GOOD CONDITION AND NOT COUNTERFEIT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE, HE SELF ADMINISTERED INSULIN, DELAYING TREATMENT, DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND REQUIRED TREATMENT FROM A HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12081 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3367613

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening| R