BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933515 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03827
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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

    IT WAS REPORTED THAT THE CUSTOMER NOTICED HER INSULIN PUMP SHUT OFF. CUSTOMER DID NOT HAVE BATTERIES AT THE TIME, TREATED HERSELF WITH A MANUAL INJECTION. WHEN CUSTOMER REPLACED BATTERIES, INSULIN PUMP WAS DISPLAYING BATTERY OUT LIMIT. CUSTOMER CLEARED THE ALARM, THEN AN A39 CAME OUT CUSTOMER CLEARED THIS ALARM AS WELL, THEN AN OFF NO POWER CAME OUT. CUSTOMER'S INSULIN PUMP WAS GOING BACK AND FORTH BETWEEN A39 AND OFF NO POWER. CUSTOMER STATED THE INSULIN PUMP ALARMED AFTER BATTERY CHANGE, AND WAS ALARMING AT THE TIME OF THE CALL. THE BLOOD GLUCOSE READING WAS 188MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411045 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR