BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1162788 · Received September 8, 2008

    Report

    Report Number
    2183996-2008-01336
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 19, 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

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT SHE FOUND INSULIN IN THE CARTRIDGE COMPARTMENT OF HER INFUSION DEVICE DURING A CARTRIDGE CHANGE. SHE BELIEVES INSULIN LEAKED FROM THE INSULIN CARTRIDGE INTO THE INFUSION DEVICE. SHE STATED THAT THERE WERE ALSO AIR BUBBLES IN THE INSULIN CARTRIDGE. SHE STATED THAT THE INSULIN CARTRIDGE DID NOT APPEAR TO BE CRACKED. SHE STATED THAT THERE WAS STILL INSULIN IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE AFTER INSERTING A NEW INSULIN CARTRIDGE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT CARTRIDGE INFUSLIN INFUSION PUMP CARTRIDGE LZG DISETRONIC MEDICAL SYSTEMS NA 32024948

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR INSULIN INFUSION PUMP| INSULIN INFUSION SET| INSULIN