BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 1522111 · Received November 2, 2009

    Report

    Report Number
    8021545-2009-00023
    Event Type
    Malfunction
    Date Received
    November 2, 2009
    Date of Event
    July 4, 2009
    Report Date
    October 28, 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

    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 A P-CAP CONNECTOR VENT TEST WERE PERFORMED. ON 2 SAMPLES, THE MEMBRANES IN THE P-CAP CONNECTORS WERE HUMID AND BOTH SAMPLES ALSO FAILED THE P-CAP CONNECTOR VENT TEST. FURTHERMORE THREE SAMPLES FAILED FLOW TESTING OF THE TUBING. 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 8200956. NO RELEVANT DEVIATIONS DURING MANUFACTURING WERE RECORDED.

    Description of Event or Problem · 1

    PATIENT STATES THAT THE INSULIN IS FLOWING FROM THE INFUSION SET TUBING EVEN THOUGH PUMP IS NOT ACTIVATED DURING PRIMING. PATIENT HAD TO GO THROUGH 3 DIFFERENT INFUSION SETS FROM INVOLVED LOT NUMBER BEFORE THE MALFUNCTION WAS SOLVED. 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-396 8200956

    Patients

    Seq Age Sex Outcome Treatment
    1 NA