BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK SET PARADIGM

    MDR report key: 2001698 · Received February 9, 2011

    Report

    Report Number
    3003442380-2011-00004
    Event Type
    Death
    Date Received
    February 9, 2011
    Date of Event
    January 5, 2011
    Report Date
    February 8, 2011
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    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 RECEIVE ANY NEW INFO REGARDING THIS CASE, WE WILL SEND A F/U REPORT. UNOMEDICAL A/S REC'D THE COMPLAINT THROUGH THE DISTRIBUTOR OF THE INFUSION SET. (B)(4).

    Description of Event or Problem · 1

    REC'D A CALL FROM (B)(6) IN (B)(6), STATING THAT (B)(6) CORONER, DR. (B)(6), REPORTED THAT CUSTOMER (B)(6) PASSED AWAY FROM DKA ON THE (B)(6) 2011. CORONER WAS NOT SURE WHAT TYPE OF INFUSION SET IT WAS, BUT MOST LIKELY A QUICK SET MMT-398 OR MIGHT BE A MIO 925. CUSTOMER WAS ORDERED BOTH IN THE PAST. DR. (B)(6) STATED THAT THE CUSTOMER WAS FOUND ON THE FLOOR AT HER UNCLE'S HOUSE WHERE SHE WAS STAYING. TIME OF DEATH 13:41 IN (B)(6). (B)(6) INITIALLY REPORTED THE DEATH, BUT IN ORDER TO GET MORE INFO, A CALL WAS PLACED TO THE CORONER. CUSTOMER WAS WEARING THE PUMP AT TIME OF DEATH. CORONER, (B)(6), SHARED THE FOLLOWING DETAILS REGARDING THE DEATH OF (B)(6). CUSTOMER HAD JUST RECENTLY RETURNED FROM A TRIP TO (B)(6) ON THE (B)(6) AND WAS FOUND DECEASED THE NEXT DAY ON THE FLOOR OF HER UNCLE'S HOME WHERE SHE WAS STAYING. THE AUTOPSY WAS PERFORMED ON THE (B)(6) AND AT THAT TIME, BG WAS WELL OVER 600 STILL. DR. (B)(6) STATED THAT WHEN THEY TOOK THE CANNULA OUT OF THE BODY, IT WAS KINKED. CORONER PROVIDED NAME AND NUMBER OF THE DECEASED MOTHER, (B)(6). MOTHER STATED THAT SHE WOULD LIKE THE PUMP SENT BACK TO HOME ADDRESS (B)(6). CORONER, DR. (B)(6), STATED THAT SHE WANTED THE PUMP SENT BACK TO THE CORONER'S OFFICE INSTEAD OF TO CUSTOMER'S FAMILY. DR. (B)(6) LATER CONFIRMED THAT SHE REC'D THE PACKAGING TO RETURN THE INSULIN PUMP AND INFUSION SET. ON THE (B)(6), DR. (B)(6) CALLED AND STATED THAT THE MOTHER HAD DECIDED AGAINST RETURNING THE INSULIN PUMP AND INFUSION SET AT THIS TIME. THE INFUSION SET AND THE INSULIN PUMP WILL REMAIN AT DR. (B)(6) OFFICE FOR THE TIME BEING. DR. (B)(6) STATED THAT A REP FROM (B)(6) CAME TO HER OFFICE AND ASSISTED HER WITH UPLOADING THE INSULIN PUMP INTO CARELINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET PARADIGM FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-398 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Death