BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3942397 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87548
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 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 ALARMED WITH A FAILED BATTERY ALERT AND NOW JUST TURNED OFF. THE BLOOD GLUCOSE READING WAS 457 MG/DL, AND THE CUSTOMER TREATED USING THE INSULIN PUMP. CONFIRMED THAT THE BATTERY DID LAST MORE THAN ONE WEEK, AS DESIGNED. THE CUSTOMER STATED THAT THE RUBBER RING AROUND THE BATTERY CAP WAS LOOSE. IT WAS ALSO REPORTED THAT THE DEVICE ALARMED NO DELIVERY TWO MONTHS PRIOR, WHICH WAS RESOLVED BY A COMPLETE SET CHANGE. ADVISED THE CUSTOMER TO MONITOR THE DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419802 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR