BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1973392 · Received January 30, 2011

    Report

    Report Number
    2032227-2011-00301
    Event Type
    Death
    Date Received
    January 30, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 20, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. THE CORONER IS ALSO RETURNING THE INFUSION SET FOR ANALYSIS. AN ATTEMPT WAS MADE TO CONTACT THE CORONER AGAIN TO FIND OUT IF THE INFUSION SET WAS IN TRANSIT TO BE RETURNED, BUT THE CORONER COULD NOT BE REACHED. WHEN THE INFUSION SET IS RETURNED, FULL PRODUCT DETAILS, INCLUDING THE EXACT MAKE AND MODEL NUMBER, WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE DISTRICT CLINICAL SUPERVISOR IN (B)(6) CALLED TO REPORT THAT THE CORONER IN (B)(6) INFORMED HER THAT A CUSTOMER HAD PASSED AWAY. THE CORONER WAS CONTACTED, AND THE FOLLOWING DETAILS WERE OBTAINED: THE CUSTOMER PASSED AWAY AT APPROXIMATED 13:41 ON (B)(6) 2011. THE CAUSE OF DEATH WAS DIABETIC KETOACIDOSIS. THE CUSTOMER HAD RETURNED FROM A TRIP TO (B)(6) ON (B)(6) 2011 AND WAS STAYING AT HER UNCLE'S HOUSE, WHERE SHE WAS FOUND LYING ON THE FLOOR DECEASED THE NEXT DAY. AN AUTOPSY WAS PERFORMED ON (B)(6) 2011, AND AT THAT TIME, THE CUSTOMER'S BLOOD GLUCOSE READING WAS STILL OVER 600 MG/DL. THE CORONER NOTED THAT WHEN THE INFUSION SET WAS REMOVED FROM THE CUSTOMER'S BODY, THE CANNULA WAS KINKED. THE CORONER WAS NOT SURE WHAT TYPE OF INFUSION SET WAS IN USE. FROM THE CUSTOMER'S ORDER HISTORY, IT APPEARS THAT THE CUSTOMER WAS LIKELY USING EITHER A QUICK-SET INFUSION SET, MODEL NUMBER MMT-398 OR MMT-396, OR A MIO INFUSION SET, MODEL NUMBER MMT-925.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Death