BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4223102 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-47438
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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. 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.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HE EXPERIENCED HIGH BLOOD GLUCOSE OF 487 MG/DL; CUSTOMER STATED THE INSULIN PUMP HAD A LOW RESERVOIR DURING THE NIGHT. CUSTOMER REPORTED THAT WHEN HE CHANGED THE BATTERY HE GETS AN EMPTY RESERVOIR ALARM AND A BLACK CIRCLE ON SCREEN; THIS OCCURRED TWO TIMES. CUSTOMER WAS ASSISTED ON CLEARING THE ALARM, SETTING THE TIME AND DATE AND PRIMING. CUSTOMER ALSO REPORTED HE RECEIVED MULTIPLE ERROR ALARMS. CUSTOMER WAS EXPLAINED THAT THE DEVICE HAD AN UNEXPECTED RESTART. CUSTOMER STATED THE INSULIN PUMP WAS NOT STORED OR NOT IN USE FOR AN EXTENDED PERIOD OF TIME AND ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705613 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR