BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3013823 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-91988
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 10, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 325MG/DL, AND THE CALLER WANTED TO MAKE SURE THE INSULIN PUMP IS FUNCTIONING PROPERLY. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE CUSTOMER WAS INVOLVED IN A CAR ACCIDENT, BUT SHE WAS NOT DRIVING, AND SHE HAS A FOOT PAIN. THE CALLER STATED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE SINCE DAYS BEFORE WHEN THE DOCTOR ADJUSTED THE SETTINGS ON THE DEVICE. THE TIME, DATE, BOLUS HISTORY, AND BOLUS WIZARD WERE CORRECT. THE DRIVE SUPPORT CAP APPEARS NORMAL. ASSISTED THE CALLER TO RUN A MANUAL PRIME AND THE INSULIN DID EXIT. PERFORMED A HIGH PRESSURE TEST AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116274 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization