BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 1522107 · Received November 2, 2009

    Report

    Report Number
    8021545-2009-00034
    Event Type
    Malfunction
    Date Received
    November 2, 2009
    Date of Event
    July 5, 2009
    Report Date
    October 29, 2009
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K991759
    Removal / Correction Number
    Z-1705-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RETURNED FOR EVALUATION. THE TUBING WAS VISUALLY INSPECTED FOR ANY TEARS AND CRACKS ON THE TUBING IT SELF AND ON THE ATTACHED CONNECTOR PARTS. FURTHERMORE A FLOW TEST AND A P-CAP CONNECTOR VEST TEST WERE PERFORMED. THE MEMBRANE IN THE P-CAP CONNECTOR WAS HUMID AND THE SAMPLE ALSO FAILED THE P-CAP CONNECTOR VEST TEST. FURTHERMORE THE SAMPLE FAILED FLOW TEST OF THE TUBING. THE REFERENCE MATERIAL WAS TESTED AND ALL SAMPLES WERE FOUND TO BE WITHIN SPECIFICATIONS. A REVIEW OF THE RELEVANT DEVICE HISTORY RECORDS AND A SEARCH FOR RELEVANT DEVIATIONS OR SIMILAR COMPLAINTS RELATED TO THE SPECIFIC DEVICE RESULTED IN 1 SIMILAR COMPLAINT FOR THE INVOLVED LOT NUMBER 8200974. NO RELEVANT DEVIATIONS DURING MANUFACTURING WERE RECORDED.

    Description of Event or Problem · 1

    PATIENT STATES THAT INSULIN IS DRIPPING FROM THE INFUSION SET TUBING AFTER PUMP MOTOR HAS STOPPED. PATIENT DOES NOT KNOW IF THERE IS A VISIBLE GAP BETWEEN PUMP PISTON AND RESERVOIR. UNOMEDICAL RECEIVED THE COMPLAINT THROUGH (B)(4), THE DISTRIBUTOR OF THE INFUSION SET. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET PARADIGM FPA UNOMEDICAL A/S MMT-397 8200974

    Patients

    Seq Age Sex Outcome Treatment
    1 NA