BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982225 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-90145
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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'S MOTHER CALLED STATING HER DAUGHTER'S INSULIN PUMP HAS BEEN ALARMING WEAK BATTERY SINCE LAST THURSDAY. CUSTOMER CHANGES THE BATTERY AND THE DEVICE TURNS ON, SHOWING AN ANTENNA ICON, BUT THEN TURNS OFF. CUSTOMER SAID THE DEVICE IS ON NOW AND GOES THROUGH CYCLES. CUSTOMER'S BLOOD GLUCOSE IS 56 MG/DL. SHE TREATED WITH BREAKFAST. CUSTOMER WAS ADVISED THE DEVICE WILL STILL FUNCTION, BUT THE BATTERY LIFE WILL BE SHORTER THAN USUAL. CUSTOMER USES ENERGIZER BATTERIES. THE BATTERY WAS NOT PREVIOUSLY USED. THE DEVICE WAS NOT BUMPED OR DROPPED. THE BATTERY CAP IS NOT LOOSE OR DAMAGED. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457358 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR