BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1030193 · Received April 14, 2008

    Report

    Report Number
    2183996-2008-00515
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Date of Event
    April 5, 2008
    Report Date
    April 5, 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
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT'S HUSBAND REPORTED THAT THERE APPEARED TO BE A SMALL AMOUNT OF MOISTURE IN THE CARTRIDGE COMPARTMENT OF THE PATIENT'S INFUSION DEVICE. HE STATED HE FIRST NOTICED THE MOISTURE AFTER THE PATIENT'S LAST CARTRIDGE CHANGE. HE WAS ADVISED TO REMOVE THE INSULIN CARTRIDGE FROM THE INFUSION DEVICE AND TO DRY THE CARTRIDGE AND CARTRIDGE COMPARTMENT WITH A COTTON SWAB. THE PATIENT WAS ASSISTED WITH REINSERTING THE INSULIN CARTRIDGE INTO THE INFUSION DEVICE. HE STATED THAT HE DOES NOT ATTACH THE ADAPTER AND INFUSION TUBING TO THE INSULIN CARTRIDGE PRIOR TO INSERTION INTO THE INFUSION DEVICE. HE WAS EDUCATED ON THE PROPER PROCEDURE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL 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 INSULIN| INSULIN INFUSION SET