BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1163439 · Received September 10, 2008

    Report

    Report Number
    2183996-2008-01379
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 31, 2008
    Report Date
    August 31, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON THE EVENT DATE, THE PT'S MOTHER CALLED FOR ASSISTANCE CHANGING THE INSULIN CARTRIDGE AND ADJUSTING THE PISTON ROD OF THE INFUSION DEVICE. SHE INSERTED AN INSULIN CARTRIDGE INTO THE INFUSION DEVICE AND PERFORMED 2 PRIMES. NO INSULIN DRIPPED FROM THE INFUSION TUBING. SHE THEN REALIZED THAT ALL OF THE INSULIN WAS DRIPPING OUT OF THE ADAPTER AND INTO THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR INSULIN| INSULIN INFUSION SET