BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 1526478 · Received November 2, 2009

    Report

    Report Number
    8021545-2009-00042
    Event Type
    Malfunction
    Date Received
    November 2, 2009
    Date of Event
    June 20, 2009
    Report Date
    October 29, 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

    EVAL SUMMARY: ONE USED DEVICE WAS RETURNED FOR EVAL. USED DEVICES: THE TUBING WAS VISUALLY INSPECTED FOR ANY TEARS OR CRACKS ON THE TUBING ITSELF 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. UNUSED DEVICES: NO UNUSED SAMPLES WERE RETURNED FOR EVAL. REFERENCE SAMPLES: THE REFERENCE MATERIAL WAS TESTED AND ALL SAMPLES WERE FOUND TO BE WITHIN SPECS. 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 8200796. NO RELEVANT DEVIATIONS DURING MFG WERE RECORDED.

    Description of Event or Problem · 1

    PT'S MOTHER STATES THAT THE INSULIN IS EXITING TUBING BEFORE PUMP IS RECORDING FLOW. PT'S MOTHER STATES THAT SHE HAS TRIED TO PRIME INFUSION SET TWICE WITH SAME RESULT. PT'S MOTHER HAS REFILLED RESERVOIR SEVERAL TIMES SINCE IT WILL NOT HOLD ENOUGH INSULIN FOR 2 DAYS AS IT NORMALLY WOULD. PT'S MOTHER SOLVED PROBLEM BY CHANGING THE INFUSION SET TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET PARADIGM FPA UNOMEDICAL A/S MMT-399 8200796

    Patients

    Seq Age Sex Outcome Treatment
    1 NA