BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT PLUS

    MDR report key: 1770748 · Received September 5, 2007

    Report

    Report Number
    1823260-2007-07777
    Event Type
    Malfunction
    Date Received
    September 5, 2007
    Date of Event
    August 13, 2007
    Report Date
    September 5, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED WHEN ATTEMPTING TO TEST WITH THE COMPACT PLUS BLOOD GLUCOSE MONITORING DEVICE, AN ERROR MESSAGE WAS GENERATED AND HE WAS UNABLE TO OBTAIN A READING TO MAKE TREATMENT DECISIONS UPON. REPORTER STATED HE WAS EXPERIENCING HYPOGLYCEMIC SYMPTOMS DURING HIS ATTEMPT TO TEST WITH THE SYSTEM AND STATED HE "PASSED OUT AT THE KITCHEN TABLE, IN AND OUT OF CONSCIOUSNESS". REPORTER INDICATED FIVE HOURS LATER, HE "CAME TO" AND SELF TREATED WITH A "GALLON ORANGE JUICE AND A HALF BOX OF (B)(6) CEREAL". NO BLOOD GLUCOSE RESULTS WERE REPORTEDLY OBTAINED ON THE SYSTEM DURING OR AFTER THE ALLEGED EVENT. NO OTHER ACTIONS WERE TAKEN OR TREATMENT WAS RECEIVED REPORTEDLY. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR LANTUS - 16UNITS ONCE DAILY| NPH INSULIN - 2 YRS - SLIDING SCALE| HUMALOG - SLIDING SCALE| LYRICA - 1 YR - THREE TIMES DAILY