BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3984466 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-90274
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 4, 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
    PA
    Reporter Occupation
    OTHER

    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 REPORTED THAT WHEN THEY PRESS BOLUS THE INSULIN PUMP DOES NOT DO ANYTHING. CUSTOMER ALSO STATED THAT THEY SAW THAT THE SCREEN OF THE INSULIN PUMP WAS BLANK. CUSTOMER STATED THAT THEY DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALERT. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 137 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460199 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR