BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1851246 · Received September 23, 2010

    Report

    Report Number
    2183996-2010-01965
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 4, 2010
    Report Date
    September 15, 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
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT'S WIFE REPORTED THE DOWN BUTTON ON THE PT'S INFUSION DEVICE IS NOT RESPONDING. PT STATED THE DOWN BUTTON IS NO LONGER RESPONDING TO PRESSES PROPERLY. PT REPORTED HE FIRST NOTICED THE ISSUE WHILE ATTEMPTING TO BOLUS. PT'S WIFE REPORTED THE BUTTON POPS OUT WHEN PRESSED AND RELEASED. PT WILL SWITCH TO BACKUP INFUSION DEVICE. 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 71 YR INSULIN| INSULIN INFUSION SET