BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1792083 · Received August 10, 2010

    Report

    Report Number
    1823260-2010-04735
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 2, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. CALLER DID NOT HAVE INFORMATION REGARDING THE UNKNOWN ACCU-CHEK SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 250 MG/DL ON THE ADVANTAGE SYSTEM AND 114 MG/DL ON AN UNKNOWN ACCU-CHEK SYSTEM WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 551238

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR ACTOS| SIMVASTATIN| METFORMIN| METOPROLOL| LOSARTAN| GLIMEPIRIDE