BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAB

    MDR report key: 8726050 · Received June 24, 2019

    Report

    Report Number
    2032227-2019-20267
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    June 18, 2019
    Report Date
    June 24, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    UDI-DI
    00643169221567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE UP ARROW BUTTON WAS HARD TO PUSH. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ALSO REPORTED THAT INSULIN PUMP HAD REJECTED BATTERY, HAD TO SET TIME AND DATE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519370 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAB PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-723RNAB A000290053 00643169221567

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR