BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3945062 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-87767
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    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

    IT WAS REPORTED THAT THE INSULIN PUMP WAS DELIVERING TOO MUCH INSULIN AND THE CUSTOMER WANTED TO RETURN THE DEVICE A YEAR AGO BUT DID NOT RETURN IT. THE CALLER STATED THAT THE CUSTOMER WAS CURRENTLY ON VACATION AND HAD SENT A TEXT MESSAGE TO THE CALLER STATING THAT THE INSULIN PUMP BROKE AND IT ALARMED MOTOR ERROR. THE CUSTOMER WAS ON BACK UP PLAN. THE CUSTOMER ALSO WROTE IN HER TEXT MESSAGE THAT SHE THINKS THE DEVICE GAVE HER A HUGE DOSE OF INSULIN. THE CALLER TOLD HER TO DRINK JUICE. THE CUSTOMER'S BLOOD GLUCOSE INCREASED TO 538 MG/DL, SHE TOOK SOME LENTUS BUT HAD NOVOLOG PRIOR TO THE LANTUS AND THE BLOOD GLUCOSE DECREASED TO 137 MG/DL. THE CUSTOMER WAS NO LONGER USING THE INSULIN PUMP AND MAY NOT HAVE THE DEVICE WITH HER. THE CALLER WAS ADVISED TO HAVE THE CUSTOMER CALL BACK FOR TROUBLESHOOTING WHEN THE DEVICE WAS AVAILABLE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421839 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR