BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1906493 · Received November 23, 2010

    Report

    Report Number
    1823260-2010-06975
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 10, 2010
    Report Date
    January 14, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A THERAPEUTIC STONE RETRIEVAL PROCEDURE OCCURRED ON (B)(6), 2007. DURING THE PROCEDURE ONE OF THE WIRES OF THE BASKET OF OUR STONE RETRIEVAL DEVICE DETACHED IN THE PATIENT'S RIGHT URETER. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN WIRE THROUGH THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZERO TIP RETRIEVAL BASKET SUCCESSFULLY. NO PATIENT COMPLICATION SUSTAINED AS A RESULT OF THE WIRE BREAK AND DETACHMENT.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 112 MG/DL ON COMPACT PLUS SYSTEM AND 269 MG/DL ON ADVANTAGE SYSTEM WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METERS AND STRIPS.

    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 551255

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR