BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 1526490 · Received November 2, 2009

    Report

    Report Number
    8021545-2009-00037
    Event Type
    Malfunction
    Date Received
    November 2, 2009
    Date of Event
    July 4, 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

    EVALUATION SUMMARY: ONE USED DEVICE WAS RETURNED FOR EVALUATION. 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. FURTHERMORE, THE USED SAMPLE FAILED FLOW TEST OF THE TUBING. UNUSED DEVICES: NO UNUSED SAMPLES WERE RETURNED FOR EVALUATION. REFERENCE SAMPLES: THE REFERENCE MATERIAL WAS TESTED AND THE MEMBRANES WERE HUMID IN THE P-CAP CONNECTORS ON 2 SAMPLES WHICH ALSO FAILED THE P-CAP CONNECTOR VENT TEST. THE REMAINING 8 SAMPLES WERE 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 8200911. NO RELEVANT DEVIATIONS DURING MANUFACTURING WERE RECORDED.

    Description of Event or Problem · 1

    PATIENT STATES THAT SHE OBSERVED INSULIN SQUIRTING OUT OF THE INFUSION SET TUBING DURING PRIMING OF HER NEW SET. THE FLOW WAS NOT RECORDED BY THE PUMP. SHE CONTINUED USE OF THE INFUSION SET AND HER BLOOD GLUCOSE LEVELS ARE NOW AT 454. PATIENT CHANGED THE INFUSION SET AND PRIMED IT WITH NO RECURRENCE OF THE MALFUNCTION. THE ELEVATED BLOOD GLUCOSE LEVELS WERE TREATED BY THE PATIENT WITH MANUAL INFECTIONS OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET PARADIGM FPA UNOMEDICAL A/S MMT-397 8200911

    Patients

    Seq Age Sex Outcome Treatment
    1 NA