BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2231685 · Received July 22, 2011

    Report

    Report Number
    2183996-2011-02082
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    May 3, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THERE ARE "BLACK POINTS" ON THE INFUSION DEVICE DISPLAY, BUT THE PT CAN STILL READ ALL OF THE NUMBERS AND LETTERS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REPLACED AND RETURNED FOR EVAL. THE INFUSION DEVICE WAS THOROUGHLY EVALUATED, AND IT WAS FOUND THE DISPLAY WINDOW IS SCRATCHED. THEREFORE, THE DISPLAY IS NO LONGER FULLY READABLE. NO "BLACK POINTS" WERE VISIBLE ON THE DISPLAY. THE DAMAGE WAS CAUSED BY A HARD MECHANICAL IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION SET| INSULIN