BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1030789 · Received April 17, 2008

    Report

    Report Number
    2183996-2008-00482
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 2, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT WHILE CHANGING HER INSULIN CARTRIDGE, THE PLUNGER BECAME STUCK TO THE PISTON ROD OF THE INFUSION DEVICE CAUSING INSULIN TO SPILL INTO THE CARTRIDGE COMPARTMENT. SHE WAS INSTRUCTED HOW TO REMOVE THE PLUNGER FROM THE PISTON ROD AND WAS ADVISED TO DRY THE CARTRIDGE COMPARTMENT WITH A COTTON SWAB. SHE WAS EDUCATED ON THE PROPER TECHNIQUE FOR REMOVING THE INSULIN CARTRIDGE FROM 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. NO PRODUCT WILL 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, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION SET