BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2872718 · Received December 13, 2012

    Report

    Report Number
    3004209178-2012-91363
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 1, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCE UNEXPLAINED HIGH BLOOD GLUCOSE OF 369MG/DL. TROUBLESHOOTING WAS PERFORMED. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. PERFORMED A HIGH PRESSURE TEST AND THE TEST FAILED TWICE. INSTRUCTED THE CALLER TO CHANGE THE ENTIRE INFUSION SET AND RESERVOIR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR