BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 1526479 · Received November 2, 2009

    Report

    Report Number
    8021545-2009-00027
    Event Type
    Malfunction
    Date Received
    November 2, 2009
    Date of Event
    July 7, 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: SEVENTEEN UNUSED DEVICES WERE RETURNED FOR EVAL. USED DEVICES: NO USED DEVICES WERE RETURNED FOR EVAL. UNUSED 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 MEMBRANES IN THE P-CAP CONNECTORS WERE HUMID ON 6 SAMPLES WHICH ALSO FAILED THE P-CAP CONNECTOR VENT TEST. REFERENCE SAMPLES: THE REFERENCE MATERIAL WAS TESTED AND 2 SAMPLES HAD HUMID MEMBRANES IN THE P-CAP CONNECTORS AND 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 8200939. NO RELEVANT DEVIATIONS DURING MFG WERE RECORDED. (B)(4)

    Description of Event or Problem · 1

    PATIENT STATES THAT INSULIN IS SQUIRTING FROM INFUSION SET TUBING DURING PRIMING OF SET. AFTER PUMP MOTOR STOPPED, INSULIN CONTINUED TO EXIT TUBING. PT STATES THERE IS A VISIBLE GAP BETWEEN PISTON AND RESERVOIR. PT STATES THAT THE MALFUNCTION OCCURRED WITH 6 SETS FROM INVOLVED LOT NUMBER. MALFUNCTION OCCURRED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET PARADIGM FPA UNOMEDICAL A/S MMT-397 8200939

    Patients

    Seq Age Sex Outcome Treatment
    1 NA