BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 8662360 · Received June 3, 2019

    Report

    Report Number
    2032227-2019-10673
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 28, 2019
    Report Date
    June 3, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM AS WELL AS RECEIVED ERRORS CODES. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE UNEXPLAINED NO DELIVERY ALARM AND REJECTED NEW BATTERY ALERT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457376 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR