BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 3216071 · Received July 10, 2013

    Report

    Report Number
    2032227-2013-02822
    Event Type
    Death
    Date Received
    July 10, 2013
    Date of Event
    October 1, 2012
    Report Date
    June 14, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CALLER IS REPORTING CUSTOMER'S DEATH. CALLER STATED, HIS WIFE PASSED DUE TO HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS OVER 600 MG/DL. THE HOSPITAL TRIED TO TREAT THE HIGH BLOOD GLUCOSE WITH IV DRIP, BUT THE VEINS WERE HARD TO FIND AND THEY DID MAKE IT. THIS EVENT HAPPED EIGHT HOURS BEFORE THE CUSTOMER PASSED AWAY. CALLER STATED THAT THE INSULIN PUMP WAS NOT THE CAUSE OF DEATH. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316792 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death