BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3790150 · Received May 5, 2014

    Report

    Report Number
    2032227-2014-02229
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 13, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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 THAT SHE HAD A SEIZURE DUE TO UNEXPLAINED HIGH BLOOD GLUCOSE. PARAMEDICS WERE CALLED AND CUSTOMER WAS TAKEN TO THE HOSPITAL. CUSTOMER STATED THAT THE BLOOD GLUCOSE READING WAS OVER 600 MG/DL WHEN PARAMEDICS ARRIVED. CUSTOMER REPORTED THAT HER INSULIN PUMP WAS NOT WORKING CORRECTLY, IT WAS ALARMING NO DELIVERY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267072 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization