BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1993381 · Received January 21, 2011

    Report

    Report Number
    2183996-2011-00044
    Event Type
    Malfunction
    Date Received
    January 21, 2011
    Date of Event
    October 12, 2010
    Report Date
    January 12, 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
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE DOWN BUTTON ON HIS INFUSION DEVICE IS NOT ALWAYS WORKING PROPERLY. PT STATED THE DOWN BUTTON DOESN¿T ALWAYS BEEP AND VIBRATE. PT REPORTED HE FIRST NOTICED THE ISSUE A COUPLE OF MONTHS AGO. PT STATED THE BUTTONS DO POP 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 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 46 YR INSULIN INFUSION SET| INSULIN