BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1032523 · Received April 22, 2008

    Report

    Report Number
    1823260-2008-03451
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE CUSTOMER WAS INVOLVED IN A EVENT WHERE SHE BECAME "ZOMBIE LIKE" WITH THE INABILITY TO ANSWER QUESTIONS AND SWEATING. THE CUSTOMER'S BLOOD GLUCOSE RESULT WAS 73 MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM. TWENTY MINUTES LATER THE CUSTOMER'S BLOOD GLUCOSE RESULT WAS 39 MG/DL ON THE PROFESSIONAL METER. THE CUSTOMER WAS TREATED WITH IV GLUCOSE AND FELT BETTER 1 HOUR AFTER TREATMENT. NEW SYSTEM SENT AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550518

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention LISINOPRIL 5MG/DAY| FUROSEMIDE 20MG/DAY| RENAL SOFT GEL CAPS - UNK DOSE - 1/DAY| LANTUS 25 UNITS/DAY| METOPROLOL 75 MG/DAY| GLIPIZIDE 10MG/DAY - "LONG TIME"| SIMVASTATIN 40MG/DAY| WARFARIN 5MG/DAY