BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 1526699 · Received October 27, 2009

    Report

    Report Number
    8021545-2009-00006
    Event Type
    Malfunction
    Date Received
    October 27, 2009
    Date of Event
    June 20, 2009
    Report Date
    October 27, 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

    (B)(4). EVALUATION SUMMARY: ONE USED DEVICE AND 10 UNUSED DEVICES WERE RETURNED FOR EVALUATION. USED DEVICE: THE TUBING WAS VISUALLY INSPECTED FOR ANY TEARS OR CRACKS ON THE TUBING IT SELF AND ON THE ATTACHED CONNECTOR PARTS. FURTHERMORE, A FLOW TEST AND A P-CAP CONNECTOR VENT TEST WERE PERFORMED. THE FLOW TEST PASSED BUT THE VENTS IN THE P-CAP CONNECTOR WERE FOUND TO BE CLOGGED. UNUSED DEVICES: A VISUAL INSPECTION AND P-CAP CONNECTOR VENT TEST WAS PERFORMED ON ALL 10 UNUSED SAMPLES. THE MEMBRANE IN THE CONNECTOR WAS FOUND HUMID ON TWO SAMPLES, WHICH ALSO FAILED THE P-CAP CONNECTOR VENT TEST. THE REMAINING 8 SAMPLES WERE ALL FOUND TO BE WITHIN SPECIFICATIONS. THE REFERENCE MATERIAL WAS TESTED AND 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 NO SIMILAR COMPLAINTS FOR THE INVOLVED LOT NUMBER 8200990. NO RELEVANT DEVIATIONS DURING MANUFACTURING WERE RECORDED.

    Description of Event or Problem · 1

    DURING PRIMING OF A NEW INFUSION SET, INSULIN WAS EXITING THE INFUSION SET TUBING WITHOUT PUMP INFLUENCE. PATIENT'S MOTHER EXPLAINED THAT THE FLOW OF INSULIN IS NOT CONTROLLED BY PUMP. THE PUMP DOES NOT REGISTER THE UNITS OF INSULIN FLOWING FROM THE TUBING. THE MALFUNCTION HAS ONLY OCCURRED WITH SETS FROM LOT NUMBER 8200990. MALFUNCTION OCCURRED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET PARADIGM FPA UNOMEDICAL A/S MMT-399 8200990

    Patients

    Seq Age Sex Outcome Treatment
    1 NA