BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2231689 · Received July 22, 2011

    Report

    Report Number
    2183996-2011-02080
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    May 17, 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 THAT AFTER RIDING A HORSE, THERE WAS A "BLACK BLOT" ON THE INFUSION DEVICE DISPLAY. 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. INFUSION DEVICE WAS THOROUGHLY EVALUATED. THE DISPLAY HAD A BLACK SPOT, AND THIS MIGHT LEAD TO MISINTERPRETATION OF INSULIN AMOUNTS. THE DAMAGE WAS CAUSED BY MECHANICAL IMPACT. AS THE PROBLEM REPORTED BY THE PT WAS RELATED TO A HANDLING ISSUE, NO CORRECTIVE OR PREVENTATIVE ACTIONS WILL BE INITIATED.

    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