BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILHOUETTE PARADIGM

    MDR report key: 1997439 · Received February 9, 2011

    Report

    Report Number
    8021545-2011-00005
    Event Type
    Death
    Date Received
    February 9, 2011
    Date of Event
    December 26, 2010
    Report Date
    February 8, 2011
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO USED OR UNUSED DEVICES WERE RETURNED AND DUE TO THE UNK LOT NUMBER, NO TESTING COULD BE PERFORMED. IF WE REC'D ANY NEW INFORMATION REGARDING THIS CASE, WE WILL SEND A F/U REPORT. UNOMEDICAL A/S RECEIVED THE COMPLAINT THROUGH (B)(4), THE DISTRIBUTOR OF THE INFUSION SET. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER'S FATHER CALLED IN TO REPORT THE DEATH OF HIS SON. SERIAL NUMBER WAS NOT VERIFIED, BECAUSE FATHER DO NOT SEE VERY WELL. FATHER STATED THAT CUSTOMER HAD FREQUENT PROBLEMS WITH LOW BG AND HAD BEEN HOSPITALIZED SEVERAL TIMES. CUSTOMER WAS WEARING THE PUMP AT TIME OF DEATH. FATHER SHARED FOLLOWING INFORMATION: ON (B)(6) 2010, CUSTOMER WAS HOSPITALIZED WITH LOW BG AT (B)(6) IN (B)(6). ON (B)(6) 2010, CUSTOMER IS FOUND PASSED OUT ON FLOOR WITH BG OF 10, AS PER PARAMEDIC TESTING, TAKEN TO (B)(6) HOSPITAL IN (B)(6). ON (B)(6) 2010, BGS WERE FINE. FATHER (B)(6) FOUND SON (B)(6) DEAD ON FLOOR AT 4:30 ON THE (B)(6) 2010. FATHER DO NOT HAVE DEAD CERTIFICATE YET. FATHER AGREES TO RETURN THE PUMP FOR ANALYSIS. FATHER REMOVED BATTERY FROM PUMP OVER A WEEK AGO BECAUSE HE COULD NOT SILENCE THE ALARM, SO PUMP HAVE BEEN WITHOUT BATTERY FOR AN EXTENDED PERIOD OF TIME, FATHER VERBALIZED UNDERSTAND THAT CRITICAL PUMP DATA WILL BE LOT AND WILL BE IRRETRIEVABLE WHEN PUMP IS RETURNED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE PARADIGM FPA UNOMEDICAL A/S MMT-377 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death