BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2141007 · Received June 16, 2011

    Report

    Report Number
    2183996-2011-01628
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEM 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 UP BUTTON ON THE INFUSION DEVICE WAS NOT FUNCTIONING PROPERLY. THIS WAS FIRST NOTICED 1 MONTH AGO WHEN PT TRIED TO BOLUS. THE UP BUTTON POPS UP AFTER IT IS PRESSED BUT HAS GOTTEN STUCK ON OCCASIONS. PT HAS USED THIS INFUSION DEVICE SINCE (B)(6) 2007 AND BOLUSES 3-4 TIMES PER DAY. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO WATER OR INSULIN INGRESS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEM INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR INSULIN| INSULIN INFUSION SET