BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2913412 · Received December 21, 2012

    Report

    Report Number
    2183996-2012-02044
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 15, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    Z-1646-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, PT REPORTED THE UP BUTTON ON THE INFUSION DEVICE IS DEFECTIVE. THIS ISSUE BEGAN INTERMITTENTLY 2-3 DAYS AGO, AND NOW THE BUTTON WILL NOT FUNCTION AT ALL. THE KEY-LOCK FEATURE IS NOT ACTIVATED. THE UP BUTTON IS NOT FLAT AND DOES NOT WORK IF PRESSED HARD. THE INFUSION DEVICE WAS NOT DROPPED ON A HARD SURFACE IN THE PAST 48 HOURS. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND HE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP