BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1250009 · Received November 14, 2008

    Report

    Report Number
    2183996-2008-01731
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 3, 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

    Description of Event or Problem · 1

    ON (B) (6) 2008, THE PT'S WIFE REPORTED THAT WHILE CHANGING THE INSULIN CARTRIDGE, THE PLUNGER BECAME STUCK TO THE PISTON ROD OF THE INFUSION DEVICE. A HALF OF A CARTRIDGE OF INSULIN SPILLED INTO THE CARTRIDGE COMPARTMENT. THE PT'S WIFE WAS INSTRUCTED HOW TO REMOVE THE PLUNGER FROM THE PISTON ROD AND TO DRY THE CARTRIDGE COMPARTMENT WITH A COTTON SWAB. THE PT DOES NOT HAVE A BACKUP 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, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR INSULIN INFUSION SET| INSULIN