BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1250020 · Received November 14, 2008

    Report

    Report Number
    2183996-2008-01740
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 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 Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT, WHILE REMOVING THE INSULIN CARTRIDGE FROM HIS INFUSION DEVICE, THE PLUNGER REMAINED ATTACHED TO THE PISTON ROD IN THE CARTRIDGE CHAMBER. HE STATED THAT ABOUT 3 UNITS OF INSULIN DRIPPED INTO THE CHAMBER WHICH HE DRIED WITH A TISSUE. HE SAID HE DOES NOT CURRENTLY SEE ANY INSULIN IN THE CHAMBER. DURING TROUBLESHOOTING WITH A COMPANY REPRESENTATIVE, THE PLUNGER WAS DETACHED FROM THE PISTON ROD. THE PATIENT WAS ADVISED TO DRY THE CHAMBER AGAIN WITH A COTTON SWAB. THE PATIENT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS 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 63 YR INSULIN| INSULIN INFUSION SET