BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3133560 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-94156
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 12, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 565MG/DL, AND THE INSULIN PUMP WAS NOT FUNCTIONING. IT WAS STATED THAT THE CUSTOMER EXPERIENCED NAUSEA AND VOMITING. TROUBLESHOOTING WAS PERFORMED, AND THE SELF TEST PASSED. A BOLUS WAS PROGRAMMED AND IT WAS RECORDED IN THE BOLUS HISTORY. REVIEWED THE ALARM HISTORY AND FOUND A BATTERY ALARM AND SEVERAL LOW RESERVOIR ALARMS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235694 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization