BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3842389 · Received June 1, 2014

    Report

    Report Number
    2032227-2014-02671
    Event Type
    Malfunction
    Date Received
    June 1, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 13, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATIONS WITH NO BATTERY ALARMS OR AUDIO/BEEP ANOMALY NOTED DURING TESTING.

    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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY FAILURE ANALYSIS THAT WAS NOT INCLUDED ON THE INITIAL DEVICE EVALUATION: THE INSULIN PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PROBLEMS WITH THE INSULIN PUMP. CUSTOMER STATED THAT THE INSULIN PUMP IS DELIVERING TOO MUCH INSULIN. THE BATTERIES WERE LASTING LESS THAN ONE WEEK. CUSTOMER WAS EXPERIENCING LOW BLOOD GLUCOSE.THE BLOOD GLUCOSE READING WAS 37 MG/DL. THE LAST BLOOD GLUCOSE READING IS 81 MG/DL. CUSTOMER TREATED LOW BLOOD GLUCOSE WITH FOOD. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320754 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR