BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACC-CHEK SPIRIT

    MDR report key: 1014071 · Received March 13, 2008

    Report

    Report Number
    2183996-2008-00344
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT SHE BEGAN USE OF HER INFUSION DEVICE WITHOUT FIRST BEING TRAINED. SHE INSERTED A FULL INSULIN CARTRIDGE INTO THE INFUSION DEVICE AND THEN REMOVED IT. THE PLUNGER OF THE INSULIN CARTRIDGE REMAINED ATTACHED TO THE PISTON ROD OF THE INFUSION DEVICE, AND THE ENTIRE CONTENTS OF THE CARTRIDGE SPILLED INTO THE CARTRIDGE COMPARTMENT. THE PT WAS EDUCATED ON THE PROPER TECHNIQUE FOR REMOVING THE INSULIN CARTRIDGE FROM THE INFUSION DEVICE. PT TRAINING WAS REQUESTED. 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 ACC-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION SET