BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK SET PARADIGM

    MDR report key: 2213124 · Received July 26, 2011

    Report

    Report Number
    3003442380-2011-00017
    Event Type
    Death
    Date Received
    July 26, 2011
    Date of Event
    November 3, 2010
    Report Date
    July 26, 2011
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNOMEDICAL HAS REQUESTED THE DISTRIBUTOR TO INVESTIGATE IF ANY FURTHER INFO COULD BE RETRIEVED REGARDING THE INCIDENT. THE REPORTER HAD AGREED TO RETURN THE INVOLVED INFUSION SET BUT THIS HAS NOT BEEN RECEIVED. SINCE THE LOT NUMBER IS NOT AVAILABLE, ANY INVESTIGATION OF RETAINED SAMPLES OR BATCH RECORDS IS NOT POSSIBLE. IF NO ADD'L INFO BECOMES AVAILABLE, UNOMEDICAL WILL CLOSE THIS CASE AND A FINAL REPORT STATING THIS WILL BE SUBMITTED NO LATER THAN (B)(4), 2011. IF THE DEVICE IS RETURNED OR A LOT NUMBER BECOMES AVAILABLE AT ANY GIVEN TIME, UNOMEDICAL WILL PERFORM VISUAL INSPECTIONS, FLOW AND LEAK TESTING AND BATCH RECORD REVIEWS TO DETERMINE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THIS WILL ALSO BE REPORTED IN A FINAL REPORT TO THE FDA.

    Description of Event or Problem · 1

    REPORTER CALLED DISTRIBUTOR (MEDTRONIC MINIMED) TO REPORT THE DEATH OF THE PT. THE CAUSE OF DEATH WAS REPORTEDLY RESPIRATORY FAILURE AND HYPOGLYCEMIC COMA. PT WAS AT (B)(6) HOSPICE AND IN THE CARE OF DR. (B)(6). PT WAS WEARING INFUSION PUMP AT TIME OF DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death