BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4251868 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52773
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    IT WAS REPORTED THE CUSTOMER WAS RECEIVING NO DELIVERY ALARMS DURING A MANUAL PRIME. THE CUSTOMER'S BLOOD GLUCOSE 495 MG/DL. TROUBLESHOOTING FOUND INSULIN WAS ABLE TO EXIT WITH A PUSH PLUNGER, BUT THE INSULIN PUMP ALARMED NO DELIVERY. THE CUSTOMER WAS ADVISED TO TRY ALL REMEDIES TO PREVENT RECURRING NO DELIVERY ALARMS. CUSTOMER ALSO STATED THEIR CANNULA WAS NOT BENT OR OCCLUDED. THE CUSTOMER ALSO STATED INSULIN WAS ABLE TO EXIT DURING A MANUAL PRIME. IT WAS ALSO FOUND THE CUSTOMER'S INSULIN PUMP DID NOT ALARM NO DELIVERY AFTER FURTHER TROUBLESHOOTING. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737991 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR