BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920884 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86580
    Event Type
    Death
    Date Received
    July 8, 2014
    Date of Event
    June 16, 2013
    Report Date
    June 24, 2014
    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

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS 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 BY THE CUSTOMER'S HUSBAND THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2013 WHILE ATTACHED TO HER INSULIN PUMP. CAUSE OF DEATH HAS NOT BEEN CONFIRMED BY A HEALTHCARE PROFESSIONAL, BUT CUSTOMER'S HUSBAND STATED IT WAS HEART AND KIDNEY FAILURE. CUSTOMER PASSED AWAY AT THE HOSPITAL AND HAD BEEN REMOVED FROM HER INSULIN PUMP FOUR DAYS PRIOR TO HER DEATH. CUSTOMER'S HUSBAND STATED THAT HER BLOOD GLUCOSE WOULD VARY DRASTICALLY WHILE HOSPITALIZED, RANGING BETWEEN 20 MG/DL TO 500 MG/DL. INSULIN PUMP WAS DONATED AND RECIPIENT WILL SEND DEVICE BACK FOR ANALYSIS. TO THE BEST OF HIS MEMORY, CUSTOMER'S HUSBAND BELIEVED SHE HAD FALLEN AND WAS UNCONSCIOUS BEFORE THEY RUSHED HER TO THE HOSPITAL. CUSTOMER REPORTEDLY HAD MANY EPISODES OF LOW BLOOD GLUCOSE LEVELS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398457 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death