BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3892329 · Received June 24, 2014

    Report

    Report Number
    2032227-2014-03312
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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

    CUSTOMER REPORTED A HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE READING WAS 117 MG/DL EARLIER ON THE NIGHT OF THE HOSPITALIZATION. THE CUSTOMER THEN ATE AND BOLUSED AROUND 9:30PM. AT 2AM THAT SAME SAME NIGHT THE CUSTOMER GOT UP TO GET SOME GLUCOSE BUT HAD TO SIT DOWN AND HIS SON CALLED THE PARAMEDICS. CUSTOMER'S BLOOD GLUCOSE READING WAS 25MG/DL WHEN THE PARAMEDICS ARRIVED. CUSTOMER STATED THAT HE WAS NOT WEARING HIS CONTINUOUS GLUCOSE MONITORING DEVICE. CUSTOMER DECLINED TROUBLESHOOT AND STATED THAT HE IS COMFORTABLE USING THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367582 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization