BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT PLUS

    MDR report key: 2163498 · Received July 7, 2011

    Report

    Report Number
    MW5021295
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ROCHE
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM A TYPE 2 DIABETIC. I USE ACCU CHEK COMPACT PLUS TO CHECK MY BLOOD SUGAR. LAST NIGHT I RECEIVED A VERY HIGH INCORRECT READING WITH THIS GLUCOMETER OF 458, WHICH I DID NOT BELIEVE TO BE TRUE. I RAN A CONTROLLED SUBSTANCE TEST WHICH SHOWED THE METER WAS IN PROPER RANGE. I RAN A SECOND BLOOD SUGAR TEST, WHICH SHOWED A BLOOD SUGAR READING OF ABOUT 120. I HAVE EXPERIENCED, WHAT I BELIEVE TO BE OTHER FALSE HIGH BLOOD SUGAR READINGS, IN THE LAST MONTH OR SO. SINCE I AM ON A SLIDING SCALE, I TAKE WHAT INSULIN DEPENDING ON THE RESULTS OF THE GLUCOMETER TEST. LESS THAN A MONTH AGO, I WOKE UP IN THE MIDDLE OF THE NIGHT, AT ABOUT 3 AM, NOT FEELING RIGHT. I CHECKED MY BLOOD SUGAR, IT WAS 24! I AM SURPRISED THAT I DID NOT PASS OUT OR GO INTO A COMA. I HAVE CONTACTED ROCHE, THE MFR OF THESE GLUCOMETERS IN REGARDS TO THIS, BUT ALL THEY ARE GOING TO DO IS TO SEND ME A NEW METER. I DID LOCATE ON THE FDA'S WEB SITE, A NOTICE OF FALSE HIGHS IN REGARDS TO THESE METERS, WITH SERIAL NUMBERS BEGINNING WITH GT, WHICH ALL OF THE METERS I HAVE BEGIN WITH. I FEEL THAT THERE ARE SERIOUS AND LIFE THREATENING PROBLEMS WITH THESE METERS. WITH A VERY LOW BLOOD SUGAR, ONE CAN GO INTO A COMA AND DIE. I BELIEVE THESE METERS SHOULD BE RECALLED AND TAKEN OFF THE MARKET. DATES OF USE: (B)(6) 2006 - (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT PLUS GLUCOMETER NBW ROCHE
    2 ACCU-CHEK COMPACT PLUS GLUCOMETER NBW ROCHE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| O