BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3171137 · Received June 14, 2013

    Report

    Report Number
    2032227-2013-02461
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    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

    THE CUSTOMER CALLED TO REPORT A LOW BLOOD GLUCOSE OF 34 MG/DL. THE CUSTOMER HAD ALREADY TREATED WITH FOOD, BUT STATED HE HAD BEEN LOW FOR ONE HOUR. THE CUSTOMER DID STATE THAT HE HAD BEEN DRINKING. DURING THE CALL, THE PARAMEDICS WERE CALLED FOR ASSISTANCE DUE TO THE CUSTOMER'S LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER HAD ALSO REPORTED A LOST SENSOR ALARM. ASSISTED THE CUSTOMER WITH THE ALARM. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270952 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention