BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1821252 · Received August 26, 2010

    Report

    Report Number
    2183996-2010-01722
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 6, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED SHE NOTICED THE DOWN BUTTON ON HER INFUSION DEVICE WAS DEFECTIVE 10 DAYS AGO WHEN SHE WAS ATTEMPTING TO ADJUST HER BASAL RATES. PATIENT STATED THE INFUSION DEVICE DID NOT RESPOND WHEN THE DOWN BUTTON WAS PRESSED. PATIENT REPORTED THE BUTTON POPS BACK UP AS NORMAL. ASSISTED PATIENT WITH SETUP OF HER BACKUP INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT 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 35 YR INSULIN| INSULIN INFUSION SET