BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2190597 · Received July 27, 2011

    Report

    Report Number
    2183996-2011-02110
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    February 4, 2011
    Report Date
    July 18, 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
    EZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THE INFUSION DEVICE DISPLAY WAS DAMAGED, "SCRATCHY," AND HARDLY READABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS RETURNED FOR EVAL, AND THE COMPLAINT WAS NOT VERIFIED DUE TO MISUSE OF THE PRODUCT. THE DISPLAY WAS BROKEN DUE TO A MECHANICAL IMPACT AND IS NO LONGER FULLY READABLE. AS THE PROBLEM REPORTED BY THE PT IS DUE TO MISHANDLING OF THE PRODUCT, 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| INSULIN INFUSION SET