BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5222362 · Received November 13, 2015

    Report

    Report Number
    2032227-2015-65627
    Event Type
    Injury
    Date Received
    November 13, 2015
    Date of Event
    May 26, 2014
    Report Date
    October 28, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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

    IT WAS REPORTED VIA INTERDEPARTMENTAL HELPLINE SOLUTIONS TRACKER THAT CUSTOMER WAS HOSPITALIZED ON (B)(6) 2014 DUE TO HAVING HIGH BLOOD GLUCOSE, BEING SICK AND THROWING UP FOR TWO DAYS. CUSTOMER DECLINED BEING TRANSFERRED TO 24 HOUR HELPLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752618 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization