BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4811198 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61296
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 11, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 SHE FOUND BLOOD IN THE TUBING AND THE RESERVOIR. THE CUSTOMER STATED HIS SITE WAS ACTIVELY BLEEDING. CUSTOMER STATED THERE WAS A BLOOD BLISTER AND BLOOD AROUND THE SITE. THE CUSTOMER IS NOT ON ANY MEDICATION THAT MIGHT CAUSE BLEEDING. BLOOD GLUCOSE VALUE WAS 400 MG/DL. SHE WAS ADVISED TO APPLY FIRM PRESSURE UNTIL BLEEDING STOPS AND CONTACT THE DOCTOR IF BLEEDING PERSISTS. SHE ALSO REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING A BOLUS DELIVERY AND REVIEWING THE SENSOR GRAPH. THE CUSTOMER CHANGED THE COMPLETE SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355710 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR