BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 1526475 · Received November 2, 2009

    Report

    Report Number
    8021545-2009-00039
    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

    EVAL SUMMARY: TWO USED DEVICES AND THREE UNUSED DEVICES WERE RETURNED FOR EVAL. USED DEVICES: THE TUBING WAS VISUALLY INSPECTED FOR ANY TEARS OR CRACKS ON THE TUBING ITSELF AND ON THE ATTACHED CONNECTOR PARTS. FURTHERMORE, A FLOW TEST AND A P-CAP CONNECTOR VENT TEST WERE PERFORMED. THE MEMBRANES IN THE P-CAP CONNECTORS WERE HUMID AND BOTH SAMPLES ALSO FAILED THE P-CAP CONNECTOR VENT TEST. UNUSED DEVICES: THE UNUSED DEVICES WERE TESTED AS THE USED DEVICES. THE MEMBRANE OF THE P-CAP CONNECTOR WAS HUMID ON 1 SAMPLE, WHICH ALSO FAILED THE P-CAP CONNECTOR VENT TEST. THE REMAINING 2 SAMPLES WERE FOUND TO BE WITHIN SPECS. REFERENCE SAMPLES: THE REFERENCE MATERIAL WAS TESTED AND ALL SAMPLES WERE FOUND TO BE WITHIN SPECS. 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 COMPLAINTS FOR THE INVOLVED LOT NUMBER 8200974. NO RELEVANT DEVIATIONS DURING MFG WERE RECORDED. (B) (4)

    Description of Event or Problem · 1

    PT STATES THAT INSULIN IS POURING OUT OF INFUSION SET TUBING WITHOUT PUMP RECORDING THE FLOW.

    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