BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1882616 · Received October 26, 2010

    Report

    Report Number
    1823260-2010-06357
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 12, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STRIPS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WOULD UNDERGO AN EXPLANT DUE TO THE DEVICE LOCATION MAKING THE PT'S SYMPTOMS WORSE AND DIFFICULTY CHARGING.

    Description of Event or Problem · 1

    CALLER REPORTED INFORM BLOOD GLUCOSE RESULTS OF 501 MG/DL AND 234 MG/DL WITHIN 1-2 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. STRIPS NOT AVAILABLE FOR RETURN, REPLACEMENT 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 551284

    Patients

    Seq Age Sex Outcome Treatment
    1