BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4201177 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-43440
    Event Type
    Death
    Date Received
    October 27, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY DUE TO SEPSIS. THE CUSTOMER'S SON DID NOT KNOW THE BLOOD GLUCOSE READING AT THE TIME OF PASSING. THE CALLER STATED THAT THE CUSTOMER HAD BEEN OFF OF INSULIN PUMP THERAPY FOR 3 WEEKS PRIOR TO PASSING AND THAT THE DEVICE HAD NO RELATION TO HIS DEATH. HE STATED THAT THE CUSTOMER HAD A KNEE REPLACEMENT, STAYED IN THE INTENSIVE CARE UNIT FOR 3 WEEKS, AND WAS BEING TREATED WITH AN INTRAVENOUS DRIP. THE CALLER DID NOT HAVE THE INSULIN PUMP, STATING THAT IT WAS AT THE MEDICAL CENTER WHERE THE CUSTOMER HAD BEEN FIRST ADMITTED PRIOR TO TRANSFER TO ANOTHER HOSPITAL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681862 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death