BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1063450 · Received June 20, 2008

    Report

    Report Number
    1823260-2008-04878
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE RESULT OF 25MG/DL ON THE ACCU-CHEK ADVANTAGE SYS AND TREATED HERSELF. TWENTY-THREE MINUTES LATER, SHE FELT "OUT OF IT" (HYPOGLYCEMIC) AND OBTAINED A 114MG/DL AND 298MG/DL WITHIN A TEN MINUTE TIMEFRAME. NO REPORTED TREATMENT GIVEN BY THE CUSTOMER OR HER HUSBAND. THE PARAMEDICS WERE NOTIFIED. ONE HR AND 42 MINUTES LATER, HER BLOOD GLUCOSE WAS 28MG/DL ON THE PROFESSIONAL METER AND SHE RECEIVED INTRAVENOUS THERAPY (UNK CONTENTS). NEW SYS SENT TO CUSTOMER 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 550540

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention ZOCOR - 80MG/DAY| AMITRIPTYLINE - 10MG/DAY| ASPIRIN 81MG/DAY - 1 YR| HUMALOG PER INSULIN PUMP - 10 YRS| LISINPORIL - 5MG/DAY