BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3123021 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-93820
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER'S FATHER, (B)(6) CALLED REGARDING THE OVER DELIVERY OF INSULIN. CUSTOMER INFORMED CALLER THAT THE INSULIN PUMP WENT CRAZY AND MAY HAVE OVER DELIVERED INSULIN. THE LAST ALARM WAS REWIND PUMP. CUSTOMER WAS TRYING TO DELIVER A BOLUS, WHEN THE INSULIN PUMP SAID "PUMP RESETTING" AND STARTED TO VIBRATE AND COUNTDOWN. CUSTOMER STATED THAT HE DROPPED THE INSULIN PUMP THE PREVIOUS DAY. CUSTOMER'S BLOOD GLUCOSE READING IS 384 MG/DL. CALLER STATED SOMETIMES THE CUSTOMER RUSHES THROUGH THE PROGRAMMING. CALLER WILL MONITOR THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224579 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR