BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1132474 · Received August 22, 2008

    Report

    Report Number
    2183996-2008-01278
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 13, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT INSULIN LEAKED FROM THE BOTTOM OF HER INSULIN CARTRIDGE INTO THE CARTRIDGE COMPARTMENT OF HER INFUSION DEVICE. SHE STATED THAT THIS OCCURRED 3 WEEKS AGO, AND SHE NOTICED THE LEAK WHILE SHE WAS PRIMING THE INFUSION TUBING. SHE STATED THE CARTRIDGE COMPARTMENT WAS FILLED WITH "ABOUT HALF AN INCH" OF INSULIN. SHE REMOVED THE INSULIN CARTRIDGE AND CLEANED THE CARTRIDGE COMPARTMENT WITH A MOIST TOWEL. SHE INSERTED A NEW INSULIN CARTRIDGE AND HAS BEEN REUSING IT SINCE THE INCIDENT. SHE WAS ADVISED NOT TO REUSE INSULIN CARTRIDGES. SHE BELIEVES THE LEAKY INSULIN CARTRIDGE WAS FAULTY AND MAY HAVE BEEN EXPOSED TO EXTREME HEAT DUE TO BEING STORED IN HER CAR. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PATIENT DID NOT RETAIN THE ALLEGED INSULIN CARTRIDGE. HER INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IACCU-CHEK SPIRIT CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG DISETRONIC MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| NSULIN INFUSION PUMP| INSULIN INFUSION SET