BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2870076 · Received December 12, 2012

    Report

    Report Number
    2032227-2012-08002
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 25, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 HE HAD UNEXPLAINED HIGH AND LOW BLOOD GLUCOSE. HE CALLED THE PARAMEDICS AND WAS HOSPITALIZED DUE TO HIGH AND LOW BLOOD GLUCOSE. THE HIGH BLOOD GLUCOSE READING WAS 450 MG/DL AT THE TIME THE PARAMEDICS ARRIVED. THE BLOOD GLUCOSE DROPPED AND HE WAS 54 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization