BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3911199 · Received July 2, 2014

    Report

    Report Number
    3004209178-2014-86377
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 A HOSPITALIZATION DUE TO A HIGH AND UNCONTROLLABLE BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 500 MG/DL AT THE TIME OF HOSPITALIZATION. THE CUSTOMER ALSO STATED THAT PRIOR TO BEING HOSPITALIZED, SHE WAS EXPERIENCING NAUSEA AND VOMITING. THE INSULIN PUMP WAS GIVING AN ALARM AS WELL. THE CUSTOMER STATED THAT A TEMPORARY BASAL WAS NOT PROGRAMMED BEFORE THE ALARM OCCURRED. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP WAS STORED WITH A DEAD BATTERY FOR AN EXTENDED PERIOD OF TIME. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385843 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization