BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET PARADIGM

    MDR report key: 1758250 · Received July 6, 2010

    Report

    Report Number
    8021545-2010-00008
    Event Type
    Malfunction
    Date Received
    July 6, 2010
    Date of Event
    September 9, 2009
    Report Date
    July 6, 2010
    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

    THE INTERNAL REFERENCE NUMBER IS SVN: (B)(4). EVAL SUMMARY: USED DEVICE: SIX USED SAMPLES WERE RETURNED FOR EVAL. THE USED DEVICES WERE VISUALLY INSPECTED AND FOUND TO BE HUMID AT THE MEMBRANE OF THE RESERVOIR CONNECTORS. A FLOW AND LEAK TEST WERE PERFORMED AND THE USED DEVICES WERE FOUND TO BE CLOGGED IN THE RESERVOIR CONNECTOR NEEDLE. A RESERVOIR CONNECTOR VENT TEST WAS PERFORMED AND THE USED DEVICES WERE FOUND TO BE CLOGGED IN THE VENTS. UNUSED DEVICES: TEN UNUSED SAMPLES WERE RETURNED FOR EVAL. THE UNUSED DEVICES FROM LOT 8201001 WERE VISUALLY INSPECTED, AND ONE UNUSED DEVICE WAS FOUND TO BE HUMID IN THE MEMBRANE OF THE RESERVOIR CONNECTOR. A FLOW AND A LEAK TEST WERE PERFORMED TO THE UNUSED DEVICES, AND FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. A RESERVOIR CONNECTOR TEST WAS PERFORMED ON THE UNUSED DEVICES AND ONE UNUSED DEVICE WAS FOUND TO BE CLOGGED IN THE VENTS. REFERENCE SAMPLES: THE RETAINED SAMPLES WERE VISUALLY INSPECTED, FLOW AND LEAK TESTED AND NO ANOMALIES WERE OBSERVED. ALL RETAINED SAMPLES WERE FOUND TO BE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    PT STATED LOW BLOOD GLUCOSE, SINCE SHE CHANGED TO A INFUSION SET FROM LO 8. SHE STATED THAT THE INFUSION SET SEEMS TO DELIVER TOO MUCH INSULIN. PT DOES NOT PRIME HER SET WHILE SHE IS CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET PARADIGM FDA FPA UNOMEDICAL A/S NA 8201001-2209015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA