BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974355 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88880
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 THE BLOOD GLUCOSE READINGS WERE NOT TRANSMITTING INTO THE INSULIN PUMP. CUSTOMER WAS ASSISTED TO SET THE METER ID NUMBER INTO THE INSULIN PUMP. CUSTOMER REPORTED THAT THE INITIAL BLOOD GLUCOSE LEVEL WAS 353 MG/DL; CUSTOMER STATED TIT WAS HIGH DUE TO EATING TOO MUCH. CUSTOMER ALSO COMPLAINED ABOUT THE SERTER NOT INSERTING THE INFUSION SETS PROPERLY. CUSTOMER CHECKED HIS BLOOD GLUCOSE AGAIN AND IT SHOWED 40 MG/DL. CUSTOMER STATED HE THINKS THE READING IS NOT CORRECT AS HE FEELS FINE AND WILL CHECK WITH A DIFFERENT METER. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450515 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 59 YR