BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK SET PARADIGM

    MDR report key: 2149024 · Received June 23, 2011

    Report

    Report Number
    3003442380-2011-20014
    Event Type
    Death
    Date Received
    June 23, 2011
    Date of Event
    February 3, 2009
    Report Date
    June 23, 2011
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNOMEDICAL DID NOT RECEIVE ANY DEVICES FROM CUSTOMER/DISTRIBUTOR. UNOMEDICAL IS STILL TRYING TO GATHER ADDITIONAL INFO AT THE DISTRIBUTOR. A NEW REPORT WILL BE SUBMITTED AS SOON AS POSSIBLE, BUT NO LATER THAN THE 8TH OF JULY 2011.

    Description of Event or Problem · 1

    UNOMEDICAL (B)(4) RECEIVED ON (B)(6) 2011, A COMPLAINT REGARDING THE DEATH OF CUSTOMER (B)(6). ON THE (B)(6) 2011, INITIAL REPORTER (B)(6) REPORTED THAT CUSTOMER (B)(6) HAD PASSED AWAY ON THE (B)(6) 2009. REPORTER STATED THAT THE DEATH OF CUSTOMER IS RELATED TO THE INFUSION SET AND/OR THE PUMP. CUSTOMER WAS SUBJECTED TO AN AUTOPSY BY MEDICAL EXAMINER (B)(6). (B)(6) STATED THAT CUSTOMER WAS WEARING THE PUMP AT THE TIME OF DEATH AND THAT CUSTOMER PASSED AWAY DUE TO THE BLOOD SUGAR ON (B)(6) 2009. EXAMINER (B)(6) IS NOT SURE IF THEY ARE GOING TO RETURN THE PUMP BACK TO MEDTRONIC MINIMED. MEDTRONIC MINIMED CONTACTED THE EXAMINER (B)(6) TO GET FURTHER INFO. ON (B)(6) 2009, (B)(6). CUSTOMER'S DEATH WAS ON (B)(6) 2009 IN THE EVENING. (B)(6) REFUSED TO GIVE MORE INFO. MEDICAL EXAMINER CALLED IN AND SAID CUSTOMER'S FAMILY WOULD LIKE ANALYSIS DONE IN HOUSE ON THE PUMP CUSTOMER WAS WEARING AT TIME OF DEATH. EXPLAINED TO MEDICAL EXAMINER (B)(6) THAT ANALYSIS CAN ONLY BE DONE IN HOUSE AND CUSTOMER'S FAMILY WOULD HAVE TO CALL IN TO HAVE PUMP SENT IN FOR ANALYSIS. (B)(6) SAID THAT CUSTOMER'S FAMILY WOULD LIKE THIS DONE IN (B)(6) AT MEDICAL EXAMINERS OFFICE, EXPLAINED THAT REPRESENTATIVE IN (B)(6) ARE ONLY SALES REPRESENTATIVE AND DO NOT HAVE ACCESS TO TOOLS OR TECHNOLOGY TO GO FULL ANALYSIS ON PUMP, EXPLAINED THAT PUMP IS VERY TECHNOLOGICALLY COMPLEX AND IS VERY EXPENSIVE PIECE OF EQUIPMENT AND PROPER ANALYSIS MUST BE DONE IN HOUSE. A SUPERVISOR CHECKED INTO THE SITUATION AND MENTIONED THAT THE TM OR DCM IS ABLE TO GO TO THE MEDICAL EXAMINERS OFFICE AND PERFORM A SELF-TEST ON THE PUMP, AND THAT THE DCM MAY BE ABLE TO DOWNLOAD THE PUMP BUT THAT STILL WILL NOT PROVIDE A FULL ANALYSIS PUMP NEEDS TO BE SENT BACK TO MEDTRONIC MINIMED FOR FULL ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET PARADIGM FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-396 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death