BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1212735 · Received October 22, 2008

    Report

    Report Number
    2183996-2008-01617
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 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
    IN, 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 TRAINER CALLED FOR ASSISTANCE WITH REMOVING AND AIR BUBBLE FROM THE INSULIN CARTRIDGE. SHE STATED THAT SHE HAD PERFORMED 2 PRIMES AND WAS NOT ABLE TO REMOVE THE AIR. SHE VERIFIED THAT THE INSULIN WAS AT ROOM TEMPERATURE AND SHE WAS PRIMING WITH THE INFUSION DEVICE IN THE UPRIGHT POSITION. SHE PERFORMED 2 MORE PRIMES AND WAS NOT ABLE TO REMOVE THE AIR BUBBLE. SHE WAS ADVISED TO INSERT A NEW INSULIN CARTRIDGE. 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 WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG DISETRONIC MEDICAL SYSTEMS NA 32174378

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR INSULIN INFUSION SET:| INSULIN INFUSION PUMP:| INSULIN: