BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 1522110 · Received November 2, 2009

    Report

    Report Number
    8021545-2009-00022
    Event Type
    Malfunction
    Date Received
    November 2, 2009
    Date of Event
    July 5, 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: ONE USED DEVICE WAS 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. THE MEMBRANE IN THE P-CAP CONNECTOR WAS HUMID AND THE SAMPLE ALSO FAILED THE P-CAP CONNECTOR VENT TEST. FURTHERMORE THE SAMPLE FAILED THE FLOW TEST 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 8200933. NO RELEVANT DEVIATIONS DURING MANUFACTURING WERE RECORDED.

    Description of Event or Problem · 1

    PATIENT STATES THAT THE INSULIN IS DRIPPING OUT EXCESSIVELY DURING PRIMING OF INFUSION SET. PATIENT STATES SHE IS ABLE TO OBSERVE A VISIBLE GAP BETWEEN PUMP PISTON AND RESERVOIR. MALFUNCTION OCCURRED WITH THREE SETS FROM INVOLVED LOT NUMBER. MALFUNCTION WAS SOLVED BY CHANGING 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-396 8200933

    Patients

    Seq Age Sex Outcome Treatment
    1 NA