BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4241229 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50083
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED HER INSULIN PUMP HAS BEEN ALARMING NO DELIVERY DURING BOLUS DELIVERIES FOR THE LAST TWENTY FOUR HOURS. SHE CHANGED HER INFUSION SET TWICE YESTERDAY, ONCE IN THE EARLY MORNING AND ONCE IN THE EARLY EVENING. SHE ALSO RECEIVED A NO DELIVERY ALARM LAST WEEK THAT WAS RESOLVED WITH AN INFUSION SET CHANGE. CUSTOMER'S BLOOD GLUCOSE WAS 448 MG/DL. INSULIN EXITED THE TUBING DURING A FIXED PRIME. CUSTOMER WAS AT WORK SO SHE COULD NOT COMPLETE TROUBLESHOOTING. SHE WAS ADVISED TO CALL WHEN SHE GETS HOME TO COMPLETE TROUBLESHOOTING. CUSTOMER'S LAST BLOOD GLUCOSE WAS 350 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724060 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention