BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1169958 · Received September 11, 2008

    Report

    Report Number
    2183996-2008-01414
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 4, 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
    CA, 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 REPORTED EXPERIENCING AIR BUBBLES IN HER INSULIN CARTRIDGES AS SOON AS THEY ARE INSERTED INTO THE INFUSION DEVICE. SHE BEGAN USE OF THE INFUSION DEVICE 10 DAYS AGO. SHE STATED THAT SHE USES ROOM TEMPERATURE INSULIN AND PROPERLY ADJUSTS THE PISTON ROD PRIOR TO INSERTION. SHE WAS ADVISED TO ATTACH THE ADAPTER AND INFUSION TUBING PRIOR TO INSERTING THE CARTRIDGE INTO THE INFUSION DEVICE. SHE STATED THAT THERE IS A "FINGERNAIL" WIDTH GAB BETWEEN THE ADAPTER AND THE INFUSION DEVICE. SHE WAS EDUCATED HOW TO PROPERLY TIGHTEN THE ADAPTER. THE PATIENT WAS INSTRUCTED HOW TO PRIME THE AIR FROM HER CURRENT INSULIN CARTRIDGE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OF 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 CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG DISETRONIC MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR INSULIN| INSULIN INFUSION PUMP| INSULIN INFUSION SET