BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2143484 · Received June 2, 2011

    Report

    Report Number
    2183996-2011-01537
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    March 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT REPORTED, THERE ARE SEGMENTS MISSING FROM THE DISPLAY OF HER INFUSION DEVICE. SHE STATED, THE MISSING SEGMENTS FROM A STRAIGHT LINE THROUGH THE MIDDLE OF THE DISPLAY. THE PT CHANGED THE BATTERY AND WAS UNABLE TO RESOLVE THE ISSUE. SHE IS ABLE TO READ THE DELIVERY AMOUNTS. THE INFUSION DEVICE HAS NOT BEEN DROPPED OR EXPOSED TO LIQUIDS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR INSULIN| INSULIN INFUSION SET