BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3812925 · Received May 15, 2014

    Report

    Report Number
    2032227-2014-02365
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 LOW BLOOD GLUCOSE. CUSTOMER STATED THAT THE PARAMEDICS WERE CALLED TO ASSIST CUSTOMER AT HOME. THE BLOOD GLUCOSE READING WAS 50 MG/DL WHEN THE PARAMEDICS ARRIVED. CUSTOMER STATED THAT SHE WAS CONNECTED DURING THE PRIMING PROCESS AND DELIVERED A FULL RESERVOIR INTO HER BODY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290760 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention