BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1870468 · Received October 6, 2010

    Report

    Report Number
    2183996-2010-02070
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 25, 2010
    Report Date
    September 29, 2010
    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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED HIS DOWN BUTTON ON HIS INFUSION DEVICE IS NO LONGER FUNCTIONING. PT STATED, HE DISCOVERED THE ISSUE WHEN THE DISPLAY WAS NOT CHANGING WHILE HE WAS ATTEMPTING TO PROGRAM A BOLUS. PT REPORTED THE BUTTON POPS BACK UP. 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 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 23 YR INSULIN| INSULIN INFUSION SET