BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4350205 · Received December 22, 2014

    Report

    Report Number
    2032227-2014-68457
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Date of Event
    November 16, 2014
    Report Date
    November 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 780 MG/DL. THE PATIENT WAS ADMITTED AT (B)(6) FROM (B)(6) 2014. THE CUSTOMER INSULIN PUMP IS OOW AND INFORMED HER OF THE COT INSULIN PUMP. THE PATIENT WAS PLACED TO LISTEN TO COT GUIDELINES. THE PATIENT WAS ASKED IF SHE WILLING TO SENT HER OOW INSULIN PUMP AND SHE AGREED. THE CUSTOMER WAS SENT A RETURNING PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842565 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization