BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3864554 · Received June 10, 2014

    Report

    Report Number
    2032227-2014-02968
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 20, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GOING TO THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE AND RUNNING OUT OF SUPPLIES FOR THE INSULIN PUMP. THE CUSTOMER STATED SHE HAD RUN OUT OF RESERVOIRS. THE CUSTOMER'S BLOOD GLUCOSE WAS 460 MG/DL AT THE EMERGENCY ROOM, AND 260 MG/DL AT THE TIME THE ISSUE WAS REPORTED. THE CUSTOMER REPORTED HEADACHES AS A SYMPTOM OF HIGH BLOOD GLUCOSE. CUSTOMER WAS TREATED WITH IV. THE CUSTOMER WAS NOT WEARING THE PUMP 12 HOURS PRIOR TO OR AT THE TIME OF THE EMERGENCY ROOM VISIT. DURING TROUBLESHOOTING, NO LEAKS WERE FOUND, HOWEVER, THE INSULIN PUMP FAILED THE HIGH PRESSURE TEST TWICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340894 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization