BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2110266 · Received May 20, 2011

    Report

    Report Number
    2183996-2011-01433
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 17, 2011
    Report Date
    April 24, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    Z-1415-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE DOWN ARROW BUTTON ON HIS INFUSION DEVICE HAS BEEN ACTING UP FOR THE PAST WEEK AND THEN TODAY AFTER LUNCH, IT STOPPED RESPONDING AT ALL. PT STATED THE BUTTON POPS BACK UP BUT THE RUBBER IS WEARING OFF OF THE DOWN ARROW BUTTON. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    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 53 YR INSULIN INFUSION SET| INSULIN