BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 1522103 · Received November 2, 2009

    Report

    Report Number
    8021545-2009-00011
    Event Type
    Malfunction
    Date Received
    November 2, 2009
    Date of Event
    July 7, 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

    ONE USED DEVICE WAS RETURNED FOR EVALUATION. 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 MEMBRANE IN THE P-CAP CONNECTOR WAS HUMID AND THE SAMPLE ALSO FAILED THE P-CAP CONNECTOR VENT TEST. FURTHERMORE, THE USED SAMPLE FAILED THE FLOW TEST OF THE ENTIRE TUBING. 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 8200820. NO RELEVANT DEVIATIONS DURING MANUFACTURING WERE RECORDED.

    Description of Event or Problem · 1

    PATIENT STATES THAT INSULIN IS SQUIRTING OUT OF THE INFUSION SET TUBING DURING PRIMING OF NEW SET. PATIENT STATES THAT INSULIN KEPT FLOWING FROM THE TUBING AFTER MOTOR ON PUMP STOPPED. THERE WAS NO VISIBLE GAP BETWEEN THE PISTON AND THE RESERVOIR OBSERVED. THE MALFUNCTION WAS SOLVED BY CHANGING THE INFUSION SET. MALFUNCTION OCCURRED PRIOR TO USE. 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 8200820

    Patients

    Seq Age Sex Outcome Treatment
    1 NA