BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1841365 · Received September 22, 2010

    Report

    Report Number
    1823260-2010-05620
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED THE ADVANTAGE SYSTEM GAVE A BLOOD GLUCOSE RESULT OF "AROUND 175" MG/DL AT A TIME WHEN THE CUSTOMER WAS SYMPTOMATIC OF HYPERGLYCEMIA. DAUGHTER CALLED AMBULANCE. CUSTOMER WAS TRANSPORTED TO HOSPITAL, WHERE RESULT ON THEIR SYSTEM ABOUT AN HOUR AND HALF AFTER THE TEST ON THE ADVANTAGE METER WAS "OVER 500" MG/DL. CUSTOMER WAS TREATED WITH INSULIN AND ADMITTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM AND A REPLACEMENT 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 ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 078 YR ZOCOR| ASPIRIN| LANTUS| "POTASSIUM CLER"| ATENOLOL| FUROSEMIDE| XALATAN| HUMALOG 75/25| ALPHAGAN