BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1243175 · Received November 7, 2008

    Report

    Report Number
    2183996-2008-01685
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 28, 2008
    Report Date
    October 28, 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
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2008, THE PATIENT REPORTED THAT "PLEASE REMOVE THE CARTRIDGE" WAS FLASHING ON THE DISPLAY OF HER INFUSION DEVICE. SHE STATED THAT SHE WAS ATTEMPTING TO CHANGE THE INSULIN CARTRIDGE AND THE PLUNGER BECAME STUCK TO THE PISTON ROD, AND INSULIN SPILLED INTO THE CARTRIDGE COMPARTMENT. SHE WAS ABLE TO REMOVE THE PLUNGER FROM THE PISTON ROD AND SHE STATED THAT INSULIN "POURED" OUT OF THE CARTRIDGE COMPARTMENT. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. SHE STATED THAT SHE WOULD SWITCH TO INJECTION THERAPY. THE PATIENT 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 EVAL.

    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 53 YR INSULIN| INSULIN INFUSION SET