BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBRACE GLUCOSE MONITORING SYSTEM

    MDR report key: 1582416 · Received January 14, 2010

    Report

    Report Number
    MW5014384
    Event Type
    Malfunction
    Date Received
    January 14, 2010
    Date of Event
    January 14, 2009
    Report Date
    January 14, 2010
    Manufacturer
    OMNIS MEDICAL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USING THE EMBRACE GLUCOSE MONITORING SYSTEM. AS COMPARED TO ANOTHER HOME TESTING METER THE EMBRACE READS APPROPX 20% HIGHER. THIS IS UNSATISFACTORY FOR THE CAREFUL MONITORING OF INSULIN REGULATION. THE COMPANY, OMNIS MEDICAL OFFERED NO SOUND EXPLANATION FOR THE DIFFERENCE. OMNIS OFFERED REPLACEMENT METER -WHICH WOULD BE THE THIRD METER-, POTENTIAL SAMPLING PROBLEMS, ALCOHOL CONTAMINATION, BLAMED COLD WEATHER AND SHIPPING ANOMALIES. DATES OF USE: (B) (6) 2009. DIAGNOSIS OR REASON FOR USE: GLUCOSE MONITORING - TYPE II DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBRACE GLUCOSE MONITORING SYSTEM NONE NBW OMNIS MEDICAL EMBRACE GLUCOSE THS015S
    2 EMBRACE GLUCOSE MONITORING SYSTEM NONE NBW OMNIS MEDICAL THS015D

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other