BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2081631 · Received April 13, 2011

    Report

    Report Number
    2183996-2011-00971
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 15, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT REPORTED THE DOWN BUTTON OF THE INFUSION DEVICE IS NOT WORKING PROPERLY. HE NOTICED, THE ISSUE WHILE ATTEMPTING TO BOLUS. DURING THE REPORT, THE PT PRESSED AND HELD BOTH THE UP AND DOWN BUTTONS SEPARATELY AND THE INFUSION DEVICE BEEPED AND 0.0 WAS DISPLAYED BUT THE INFUSION DEVICE DID NOT VIBRATE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED 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 64 YR INSULIN INFUSION SET| INSULIN