BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3813000 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-84619
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 25, 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

    THE CUSTOMER REPORTED BEING IN THE HOSPITAL WITH AND INFECTION AND HE WAS GIVEN ANTIBIOTICS. THE CALLER JUST INQUIRED TO SEE IF THERE WERE ANY ISSUES WITH THE INSULIN PUMP. THE CUSTOMER STATED THAT EVERY TWO HOURS SHE WAS UP, COULD NOT SLEEP, AND WAS DEHYDRATED AND VOMITING. THE BLOOD GLUCOSE AT TIME OF ADMISSION WAS ALMOST 500MG/DL. THE CUSTOMER CALLED BACK AND HIS GLUCOSE LEVEL WAS STILL RUNNING HIGH. TROUBLESHOOTING WAS PERFORMED, AND NO DAMAGE TO THE DRIVE SUPPORT CAP NOTED. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD SETTINGS WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND A BUTTON ERROR ALARM AND NO DELIVERY ALARM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291178 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization