BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3110205 · Received May 13, 2013

    Report

    Report Number
    3004209178-2013-93393
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    February 28, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. UNIT WAS RECEIVED WITH SCRATCHED DISPLAY WINDOW AND BROKEN RESERVOIR TUBE LIP. NO LOOSE DRIVE SUPPORT DISK NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED TWICE DUE TO HIGH BLOOD GLUCOSE AND DKA. THE FIRST HOSPITALIZATION WAS ON (B)(6) 2013 AND THE BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS 555 MG/DL. THE SECOND HOSPITALIZATION WAS ON (B)(6) 2013 AND THE BLOOD GLUCOSE READING WAS ALSO OVER 500 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210432 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization