BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4854862 · Received June 18, 2015

    Report

    Report Number
    3004209178-2015-66600
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 30, 2015
    Report Date
    May 30, 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

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE OF 412 MG/DL. THE CUSTOMER DID NOT MENTION ANY DETAILS OF TREATMENT FOR THE HIGH BLOOD GLUCOSE. THE CUSTOMER WAS ADVISED TO REPLACE PLUNGER AND MANUALLY PUSH PLUNGER VERY SLOWLY, WHILE KEEPING THE RESERVOIR STRAIGHT, AND VERIFY INSULIN EXITS THE TUBING. THE CUSTOMER STATES THE INSULIN DID EXIT. CUSTOMER WAS ADVISED TO REWIND PUMP, REINSERT THE RESERVOIR INTO PUMP AND RUN MANUAL PRIME TO AT LEAST 5.0 UNITS. THE CUSTOMER HAD A MOTOR ERROR ALARM EARLIER, BUT THEIR INSULIN PUMP WORKED AS DESIGNED AFTER TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396314 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other