BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3970015 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88382
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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'S FIANCÉ REPORTED THAT THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE READINGS OF 500 MG/DL. CUSTOMER BELIEVES THAT THE HIGH READINGS MAY BE DUE TO THE HEAT. CUSTOMER STATED THAT THEY HAVE TREATED WITH A MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP APPEARED TO BE NORMAL. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 162 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446555 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR