BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4812918 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61635
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 12, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HE EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND RECEIVED THE NO DELIVERY ALARM ON THE INSULIN PUMP AFTER CHANGING THE INFUSION SET. THE CUSTOMER'S BLOOD GLUCOSE WAS 428 MG/DL. THE CUSTOMER TREATED THE HIGH BLOOD GLUCOSE WITH INSULIN PUMP THERAPY. THE CUSTOMER EXPLAINED THAT HE HAD TO PROGRAM NINE DIFFERENT BOLUSES IN ORDER TO COMPLETE THE ENTIRE DELIVERY. WHILE TROUBLESHOOTING, THE CUSTOMER WAS ADVISED TO PERFORM A 5 UNIT FIXED PRIME, AND THE CUSTOMER STATED THAT INSULIN EXITED. THE CUSTOMER WAS UNABLE TO EXAMINE THE CANNULA OF THE INFUSION SET AT THE TIME OF THE CALL. THE CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE INFUSION SET. THE CUSTOMER DID NOT RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354389 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR