BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841783 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02711
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 NURSE HOSPITALIZATION DUE TO HYPOGLYCEMIC EVENT. CALLER ALSO STATED THAT THE INSULIN PUMP WAS NOT GIVING ANY BASAL INSULIN. THE BLOOD GLUCOSE READING DURING THE TIME OF THE FIRST HOSPITALIZATION WAS 19 MG/DL. NURSE STATED THAT THE CUSTOMER HAS A HISTORY OF EXPERIENCING LOW BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING DURING THE TIME OF THE CALL WAS 591 MG/DL. THE NURSE ALSO REPORTED THAT SHE BELIEVES THE CUSTOMER WAS NOT EATING AS ADVISED; SHE DOES NOT BELIEVE IT IS AN INSULIN PUMP ISSUE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319576 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization