BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3110047 · Received May 13, 2013

    Report

    Report Number
    2032227-2013-01932
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 STATED THAT SHE EXPERIENCED A HIGH BLOOD GLUCOSE OF 263 MG/DL, AND FEELS THAT THE INSULIN PUMP IS UNDER DELIVERING. THE CUSTOMER FELT THAT IT WAS UNDER DELIVERING BECAUSE THE INSULIN DOESN'T APPEAR TO BE MOVING IN THE RESERVOIR. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. ADVISED THE CUSTOMER TO MONITOR THE INSULIN PUMP AND CALL BACK AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211234 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR