BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2192683 · Received August 5, 2011

    Report

    Report Number
    1823260-2011-04218
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 29, 2011
    Report Date
    October 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE ADVANTAGE SYSTEM (LOT NUMBER 551528, EXPIRATION DATE 06/30/2012). (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 295 MG/DL AND 250 MG/DL ON THE ADVANTAGE SYSTEM WHILE USING COMFORT CURVE TEST STRIPS, AND RESULTS OF 121 MG/DL AND 119 MG/DL ON THE COMPACT PLUS SYSTEM. THE REPORTED VALUES WERE OBTAINED 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 551528

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR GLIPIZIDE| CRESTOR| JANUVIA| XANAX