BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9133145 · Received September 30, 2019

    Report

    Report Number
    2032227-2019-70547
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    March 24, 2018
    Report Date
    September 30, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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

    MEDTRONIC LEGAL RECEIVED INFORMATION THAT THE CUSTOMER HAD HIGH OR LOW BLOOD GLUCOSE LEVEL FROM (B)(6). THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930900 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 50 YR Other