BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1893946 · Received November 3, 2010

    Report

    Report Number
    2183996-2010-02217
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 28, 2009
    Report Date
    October 28, 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
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED HAVING SOME ISSUES WITH HIS DOWN ARROW BUTTON NOT FUNCTIONING PROPERLY ON HIS BACKUP INFUSION DEVICE. PT STATED HE NOTICED THE ISSUE WHILE HE WAS ATTEMPTING TO DELIVER A BOLUS. PT REPORTED THE BUTTON WAS NOT FUNCTIONING PROPERLY OVER A YEAR AGO. PT STATED THE BUTTON POPS BACK OUT AFTER BEING 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 32 YR INSULIN INFUSION SET| INSULIN