BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2062814 · Received April 12, 2011

    Report

    Report Number
    2032227-2011-00907
    Event Type
    Death
    Date Received
    April 12, 2011
    Date of Event
    January 15, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY FROM RENAL DISEASE, DIABETES AND HYPERTHYROIDISM. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH, AND WAS HAVING A DIFFICULT TIME KEEPING HER BLOOD GLUCOSE LEVELS FROM DROPPING. THE CUSTOMER OFTEN REMOVED THE INSULIN PUMP DUE TO HER BLOOD GLUCOSE LEVELS GOING LOW. THE NEXT OF KIN AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522PNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death