BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3873319 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-85737
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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'S NURSE CALLED IN TO REPORT THAT THE CUSTOMER WAS IN THE HOSPITAL FOR HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS. THE CUSTOMER'S BLOOD GLUCOSE WAS 753 MG/DL. THE SYMPTOMS OF HIGH BLOOD GLUCOSE LEVELS THAT THE CUSTOMER EXPERIENCED WERE NAUSEA AND DIARRHEA. THE NURSE ALSO STATES THAT THERE ARE ISSUES WITH THE PUMP. SHE SAID THAT THE PUMP WAS RECEIVING MULTIPLE NO DELIVERY ALARMS. TROUBLESHOOTING WAS PERFORMED, AND NO DAMAGE TO THE DRIVE SUPPORT CAP NOTED. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. PERFORMED THE HIGH PRESSURE TEST AND PASSED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349318 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization