BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP PRODUCT CODE: OYC

    MDR report key: 8173089 · Received December 18, 2018

    Report

    Report Number
    2032227-2018-76494
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    June 29, 2018
    Report Date
    December 18, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 CUSTOMER HAD SITE ISSUES. IT WAS REPORTED THAT CUSTOMER EXPERIENCED TENDERNESS AT SITE AFTER CHANGING INFUSION SET. THERE WERE NO SIGNS OF INFECTION AT SITE. CUSTOMER¿S BLOOD GLUCOSE WAS 400 MG/DL. CUSTOMER TREATED WITH ORAL GLUCOSE AND BLOOD GLUCOSE DROPPED TO 59 MG/DL. INSULIN PUMP IS NOT EXPECTED TO RETURN FOR FAILURE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014298 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP PRODUCT CODE: OYC PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other FRN-UNK-RSVR, UNOMED SET