BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SE PARADIGM

    MDR report key: 1526700 · Received October 27, 2009

    Report

    Report Number
    8021545-2009-00007
    Event Type
    Malfunction
    Date Received
    October 27, 2009
    Date of Event
    June 28, 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: FOUR USED DEVICES WERE RETURNED FOR EVALUATION. USED DEVICES: 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. THREE USED SAMPLES WERE OCCLUDED AND THE MEMBRANES IN THE P-CAP CONNECTOR WERE HUMID. THESE 3 SAMPLES FAILED THE P-CAP CONNECTOR VENT TEST. ONE USED SAMPLE WAS FOUND TO BE WITHIN SPECIFICATIONS FOR BOTH TESTS. UNUSED DEVICES: NO UNUSED DEVICES RETURNED FOR EVAL. REFERENCE SAMPLES: 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 8201009. NO RELEVANT DEVIATIONS DURING MANUFACTURING WERE RECORDED.

    Description of Event or Problem · 1

    PATIENT'S FATHER EXPLAINS THAT WHEN TRYING TO PRIME A NEW INFUSION SET, THE INSULIN IS SQUIRTING OUT OF THE TUBING BEFORE THE PUMP PISTON MAKES CONTACT WITH THE INSULIN RESERVOIR IN THE INFUSION PUMP. PATIENT'S FATHER FURTHERMORE STATES THAT THERE IS A QUARTER OF AN INCH VISIBLE GAP BETWEEN RESERVOIR AND PISTON. NO DISCREPANCY BETWEEN THE RECORDED RESERVOIR VOLUME ON THE PUMP DISPLAY, AND THE ACTUAL RESERVOIR VOLUME. THE MALFUNCTION WAS SOLVED BY CHANGING ONE INFUSION SET AND SIX RESERVOIRS. THE MALFUNCTION OCCURRED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SE PARADIGM FPA UNOMEDICAL A/S MMT-399 8201009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA