BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK SET PARADIGM

    MDR report key: 1976401 · Received January 27, 2011

    Report

    Report Number
    3003442380-2011-00001
    Event Type
    Death
    Date Received
    January 27, 2011
    Date of Event
    September 26, 2010
    Report Date
    January 26, 2011
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: USED DEVICE: ONE USED DEVICE WAS RETURNED FOR EVAL. A VISUALLY INSPECTION AND A LEAK TEST WAS CONDUCTED ON THE USED DEVICE AND THE DEVICE WAS FOUND TO BE WITHIN PRODUCT SPECIFICATION. FURTHERMORE, UNOMEDICAL A/S CONDUCTED A FLOW TEST ON THE USED DEVICE AND THE DEVICE WAS FOUND TO BE CLOGGED IN THE RESERVOIR CONNECTOR NEEDLE. UNUSED DEVICES: NO UNUSED DEVICES WERE RETURNED FOR EVAL. REFERENCE SAMPLES: THE RETAINED SAMPLES WERE NOT TESTED DUE TO MISSING LOT NUMBER.

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER IN LAW, (B)(6), CALLED IN STATING THAT HER FATHER IN LAW, (B)(6), WAS DECEASED. CUSTOMER WAS NOT WEARING THE PUMP AT THE TIME OF DEATH. (B)(6) STATED THAT CAUSE OF DEATH WAS A HEART ATTACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET PARADIGM FPA UNOMEDICAL A/S MMT-396 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death