BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2153748 · Received July 7, 2011

    Report

    Report Number
    1823260-2011-03653
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 28, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER WAS UNABLE TO OBTAIN THIS INFORMATION. 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 551467, EXPIRATION DATE 02/29/2012). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN THE AVIVA SYSTEM.

    Additional Manufacturer Narrative · 1

    MANUFACTURER WAS UNABLE TO OBTAIN THIS INFORMATION. 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 551467, EXPIRATION DATE 02/29/2012). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN THE AVIVA SYSTEM. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULT OF 255 MG/DL ON THE ADVANTAGE SYSTEM WHILE USING COMFORT CURVE TEST STRIPS, AND RESULT OF 96 MG/DL ON THE AVIVA 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 551467

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR