BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1991484 · Received January 28, 2011

    Report

    Report Number
    2183996-2011-00090
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    October 19, 2010
    Report Date
    January 19, 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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED BOTH HER UP AND DOWN BUTTONS ARE NOT WORKING. PT STATED SHE NOTICED THE BUTTONS WERE NOT WORKING WHEN SHE WOULD HAVE TO PRESS THE BUTTONS SEVERAL TIMES BEFORE THE INFUSION DEVICE VIBRATED OR BEEPED. PT REPORTED SHE NOTICED THE ISSUE A FEW MONTHS AGO. PT STATED THE BUTTONS POP BACK OUT WHEN PRESSED. 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 43 YR INSULIN INFUSION SET| INSULIN