BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2002111 · Received February 4, 2011

    Report

    Report Number
    2183996-2011-00118
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 23, 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, PT REPORTED THE DOWN BUTTON ON THE INFUSION DEVICE WAS NOT FUNCTIONING PROPERLY. THIS WAS FIRST NOTICED A FEW DAYS PRIOR TO REPORT WHEN HE ATTEMPTED TO PROGRAM A BOLUS. THE DOWN BUTTON COMPLETELY STOPPED FUNCTIONING ON (B)(6) 2011. HE HAS USED THIS INFUSION DEVICE FOR 4-5 YEARS AND BOLUSES AT LEAST 5 TIMES PER DAY. THE DOWN BUTTON DOES POP UP AFTER IT IS PRESSED. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    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 51 YR INSULIN INFUSION SET| INSULIN