BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1761310 · Received July 20, 2007

    Report

    Report Number
    1823260-2007-06369
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    July 7, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED BLOOD GLUCOSE RESULTS OF 78 MG/DL, 152 MG/DL, 85 MG/DL, 131 MG/DL, AND 221 MG/DL OBTAINED BACK-TO-BACK ON THE ADVANTAGE SYSTEM WITHIN 5 MINUTES. REPORTER STATED CUSTOMER WAS FEELING NO SYMPTOMS AND NO TREATMENT/ACTION WAS 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 TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549536

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR HUMALOG 75/25 - 30 UNITS AM, 50 UNITS PM| REVLIMID - 10MG DAILY