BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1002503 · Received February 25, 2008

    Report

    Report Number
    1823260-2008-01837
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    January 30, 2008
    Report Date
    February 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A DISCREPANT BLOOD GLUCOSE RESULT OF 598 MG/DL ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF LO (LESS THAN 10 MG/DL) ON THE PROFESSIONAL METER WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER INDICATED THAT THE EMTS WERE CALLED BECAUSE SHE HAD PASSED OUT, AND THEY TOOK HER TO THE HOSPITAL WHERE THE DISCREPANT RESULTS WERE OBTAINED. REPORTER STATED SHE WAS TREATED WITH FOOD AND DIALYSIS FOR HER KIDNEYS, THEN RELEASED 1 WEEK LATER. NO OTHER ACTIONS WERE REPORTEDLY TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. 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 COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE - LFR NBW ROCHE DIAGNOSTICS 549808

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R ISOSORBIDE - 2-3 MONTHS - 10MG TWICE DAILY| METOPROLOL - 2-3 MONTHS - 100MG ONCE DAILY| AMLODIPINE - 2-3 MONTHS - 10MG ONCE DAILY| HUMULIN 70/30 - 90 UNITS| ISOSORBIDE DINITRATE - 2-3 MOS 10MG 3 TIMES DAILY| GABAPENTIN - 3-4 MONTHS - 300MG ONCE DAILY