BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920290 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86607
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. THE BOLUSES WERE NOT SHOWING UP IN THE HISTORY. THE BLOOD GLUCOSE AT THE TIME OF THE EVENT WAS 700 MG/DL. DURING THE HOSPITALIZATION THE BLOOD GLUCOSE HAS DECREASED TO 110 MG/DL. THE SENSOR READINGS HAVE BEEN INCORRECT. THE INSULIN PUMP WOULD TELL HER SHE IS LOW, BUT THE BLOOD GLUCOSE READING WOULD BE 200 TO 300 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397059 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization