BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3842381 · Received June 1, 2014

    Report

    Report Number
    2032227-2014-02669
    Event Type
    Injury
    Date Received
    June 1, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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.

    Description of Event or Problem · 1

    THE CALLER STATED THAT HER FATHER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS OF 24 MG/DL. THE PATIENT WAS EXPERIENCING SEIZURES, TWITCHING, HAD EYES WIDE OPEN, AND WAS SWEATING AND DROOLING. HE WAS TREATED BY EMERGENCY MEDICAL STAFF WHO ADMINISTERED A SHOT WHICH BROUGHT HIS BLOOD GLUCOSE LEVELS UP TO 191 MG/DL. WHILE IN THE HOSPITAL, THE PATIENT'S BLOOD GLUCOSE LEVELS WENT DOWN TO 38 MG/DL, THEN HE WAS STABILIZED AND RELEASED. THE FOLLOWING DAY, THE CALLER'S FATHER EXPERIENCED ANOTHER LOW BLOOD GLUCOSE LEVEL OF 46 MG/DL BUT WAS NOT HOSPITALIZED BECAUSE THEY WERE ABLE TO TREAT THIS AT HOME, AND BROUGHT BLOOD GLUCOSE LEVELS BACK UP WITHIN THREE AND A HALF HOURS. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320681 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization