BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4221393 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46691
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    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

    CUSTOMER REPORTED EXPERIENCING HIGH BLOOD GLUCOSE OF 574 MG/DL, TREATED WITH MANUAL INJECTIONS. CUSTOMER ALSO REPORTED THE INSULIN PUMP HAD SEVERAL PIN HEAD AIR BUBBLES CLOSE TO THE RESERVOIR COMPARTMENT. CUSTOMER WAS ADVISED TO DO A FIXED PRIME UNTIL AIR BUBBLES ARE NO LONGER VISIBLE. CUSTOMER STATED THE BUBBLES WENT OUT, BUT OTHER BUBBLES APPEARED. CUSTOMER STATED THEY PUT THE INSULIN IN THE RESERVOIR AFTER ONE OR TWO MINUTES OF TAKING IT OUT OF THE FRIDGE. CUSTOMER WAS ADVISED TO DO A SET CHANGE AIR BUBBLE DID NOT PERSIST AFTER SET CHANGE. TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE WAS PERFORMED AND BUBBLES WERE NOTED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701513 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR