BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982068 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-90017
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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'S FATHER REPORTED THAT THE CUSTOMER WAS HAVING HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 469 MG/DL AND WAS TREATED WITH THE INSULIN PUMP. THE CUSTOMER'S FATHER STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP WHILE SWIMMING IN A POOL, HOWEVER, THERE WERE NO SIGNS OF MOISTURE IN THE INSULIN PUMP. THE CUSTOMER'S FATHER ALSO STATED THAT THE SITE LOOKED RAISED WITH SOME LITTLE BUMPS AND THAT THE FAMILY IS CURRENTLY ON VACATION, SO CUSTOMER IS LESS ACTIVE AND EATING COOKIES AND OTHER FOODS THAT THE CUSTOMER NORMALLY DOES NOT EAT. DURING TROUBLESHOOTING, AIR BUBBLES WERE FOUND IN THE TUBING. THE CUSTOMER'S MOTHER STATED THAT THERE WERE AIR BUBBLES IN THE RESERVOIR AND TUBING. THE CUSTOMER'S FATHER STATED THAT THEY WERE USING INSULIN FROM INSULIN PENS. THE CUSTOMER'S MOTHER STATED THAT THEY WILL GET A VIAL OF INSULIN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457072 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH B1523NAHJ

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention