BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3851082 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-85225
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    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 CUSTOMER'S NURSE REPORTED HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 20 MG/DL. THE CUSTOMER'S BLOOD GLUCOSE DURING HOSPITALIZATION WAS 41 MG/DL. THE CUSTOMER WAS TREATED WITH A MANUAL INJECTION IN THE AMBULANCE. A FEW DAYS LATER THE CUSTOMER REPORTED THAT THE INSULIN WAS SQUIRTING OUT WHEN SETTING UP A NEW INFUSION SET. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329622 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization