BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3081677 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-92834
    Event Type
    Death
    Date Received
    April 29, 2013
    Date of Event
    December 28, 2012
    Report Date
    April 6, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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. 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

    CUSTOMER'S HUSBAND CALLED TO REPORTED THE PASSING OF HIS WIFE. CALLER STATED THAT THE CAUSE OF DEATH WAS DUE TO DIABETES. CALLER STATED THAT THE CUSTOMER HAD FALLEN AGAINST A BATHTUB AND HAD BROKEN SOME BONES. CALLER STATED THAT SHE BEGAN TO SPIT BLOOD, PARAMEDICS WERE CALLED AND CUSTOMER WAS HOSPITALIZED FOR 36 HOURS BEFORE PASSING. CALLER STATED THAT THE CUSTOMER ALSO HAD HEART PROBLEMS, LEUKEMIA AND SEIZURES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183642 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death