BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3081257 · Received April 26, 2013

    Report

    Report Number
    2032227-2013-01539
    Event Type
    Death
    Date Received
    April 26, 2013
    Date of Event
    March 24, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY DUE TO CARDIAC ARREST. THE CUSTOMER'S LAST KNOWN BLOOD GLUCOSE READING WAS 118 MG/DL. IT WAS STATED THAT THE CUSTOMER WENT TO THE MOVIES WITH HIS WIFE. WHEN THE MOVIE ENDED, THE CUSTOMER BEGAN HAVING ISSUES, AND BECAME UNRESPONSIVE. THE PARAMEDICS WERE CALLED, AND HE WAS TAKEN TO THE HOSPITAL. IT WAS STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CALLER STATED THAT SHE WILL BE RETURNING THE INSULIN PUMP TO HER DISTRIBUTOR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180822 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death UNOMEDICAL INFUSION SET