BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4780684 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-57371
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 AND REPORTED HER BLOOD GLUCOSE WENT UP TO 457 MG/DL. SHE TREATED WITH THE INSULIN PUMP AND BLOOD GLUCOSE WENT DOWN TO 405 MG/DL WITHIN ABOUT TWENTY MINUTES. TROUBLESHOOTING WAS OFFERED, BUT CUSTOMER STATED STRESS WAS CAUSING THE HIGH BLOOD GLUCOSE LEVELS. CUSTOMER STATED SHE WAS RECEIVING METER BLOOD GLUCOSE NOW ALERTS, BUT WAS NOT BEING PROMPTED TO CALIBRATE. SHE WAS ADVISED SHE MAY WANT TO WAIT AT LEAST AN HOUR TO CALIBRATE, SINCE BLOOD GLUCOSE WAS DROPPING, TO AVOID CALIBRATION ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325257 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR