BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3852410 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-85460
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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 REPORTED HAVING SYMPTOMS OF HIGH BLOOD GLUCOSE AND WOKE UP VOMITING. DURING THE CALL, THE CUSTOMER MENTIONED BEING HOSPITALIZED WITH HIGH BLOOD GLUCOSE OF 509MG/DL. THE CALLER STATED THAT SHE CHANGED THE INFUSION SET BEFORE BEDTIME AND THEN WENT TO SLEEP. THE CUSTOMER HAD HYPERGLYCEMIA AND WAS TREATED WITH TWO IV'S OF NOVOLOG. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329113 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 28 YR Hospitalization