BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6174378 · Received December 14, 2016

    Report

    Report Number
    2032227-2016-49760
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Date of Event
    November 16, 2016
    Report Date
    November 16, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    PATIENT

    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 DEVICE ALARMED RADIOFREQUENCY FAILED SELF TEST ALARM. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER WAS ADVISED THE DEVICE NEED TO BE REPLACED. CUSTOMER DECLINED THE REPLACEMENT. CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823487 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR