BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6054521 · Received October 25, 2016

    Report

    Report Number
    2032227-2016-34305
    Event Type
    Death
    Date Received
    October 25, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 17, 2016
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN A HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2016. THE OFFICIAL CAUSE OF DEATH IS STILL UNKNOWN. THE CALLER STATED THAT THE NIGHT BEFORE, THE CUSTOMER FELL AND HURT HIS ARM. THE NEXT MORNING HE DID NOT GO TO WORK, STAYED IN BED, AND HAD SHIVERS. THE CALLER STATE THAT AROUND 4:00AM THE CUSTOMER HAD INSULIN REACTION AND HAD LOW BLOOD GLUCOSE WHICH THE CALLER TREATED AND THE CUSTOMER'S BLOOD GLUCOSE CAME BACK UP. AROUND 4:30AM THE CALLER HEARD A GASP. THE CUSTOMER WAS TAKEN TO THE HOSPITAL BECAUSE HE WAS NOT FEELING GOOD. AT THE TIME OF DEATH, THE CUSTOMER'S BLOOD GLUCOSE WAS 500 MG/DL. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER DID NOT USE SENSORS. THE CALLER DECLINED RETURNING THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704323 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death