BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1021510 · Received March 26, 2008

    Report

    Report Number
    2183996-2008-00388
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 3, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K060873
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED HAVING ISSUES WITH AIR BUBBLES IN HIS INSULIN CARTRIDGE SINCE BEGINNING USE OF THE INFUSION DEVICE. HE STATED HE ONLY USES ROOM TEMP INSULIN AND HE ATTACHES HIS ADAPTER AND INFUSION TUBING TO THE INSULIN CARTRIDGE BEFORE INSERTION INTO THE INFUSION DEVICE. HE STATED THAT HE IS CONFIDENT THAT THE LUER CONNECTION OF THE INFUSION TUBING IS SECURE. TO TROUBLESHOOT, THE PT WAS SENT DIFFERENT TYPES OF INFUSION TUBING. FURTHER ATTEMPTS TO CONTACT THE PT WERE UNSUCCESSFUL. THE PT CALLED BACK AT ABOUT 18 DAYS LATER, AND REPORTED THAT THE REPLACEMENT INFUSION TUBING DID NOT RESOLVE THE ISSUE. HE WAS REQUESTED TO RETURN HIS INSULIN CARTRIDGES FOR EVAL ON A SEPARATE INCIDENT. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. NO PROD WILL BE RETURNED FOR EVAL.

    Devices

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

    Patients

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