BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 8747203 · Received July 1, 2019

    Report

    Report Number
    2032227-2019-22950
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    June 25, 2019
    Report Date
    June 30, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 INSULIN PUMP BUTTONS WOULD STICK DOWN WHEN PRESSED AND WERE NOT RESPONSIVE. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT INSULIN PUMP BUTTONS NEED TO PRESS TWO OR THREE TIMES AND THERE WAS CRACK ON THE INSULIN PUMP SCREEN WHICH DID NOT AFFECT THE ABILITY TO READ. THE CUSTOMER ALSO MENTIONED THAT THE INSULIN PUMP WAS MAKING ODD POPPING SOUND. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540787 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 39 YR