BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2946146 · Received February 6, 2013

    Report

    Report Number
    1823260-2013-00722
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 19, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Description of Event or Problem · 1

    CALLER STATES THAT THE CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS WITHIN 10 MINUTES: 250 MG/DL ON THE CUSTOMER'S ADVANTAGE SYSTEM; 89 MG/DL, 90 MG/DL, AND 91 MG/DL ON TWO PROFESSIONAL ADVANTAGE SYSTEMS. CALLER WAS UNABLE TO PROVIDE WHICH OF THE PROFESSIONAL ADVANTAGE SYSTEMS GAVE WHICH RESULT. INFORMATION ABOUT PROFESSIONAL ADVANTAGE METERS WAS NOT AVAILABLE AT THE TIME OF THE CALL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51245 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551890

    Patients

    Seq Age Sex Outcome Treatment
    1 079 YR LISINOPRIL| NON-ACCU-CHEK BLOOD SUGAR METER| NON-ACCU-CHEK LANCET DEVICE| METFORMIN