BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3841733 · Received May 30, 2014

    Report

    Report Number
    2032227-2014-02714
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH
    Reporter Occupation
    OTHER

    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

    THE CUSTOMER REPORTED UNEXPLAINED HIGHS AND LOWS. CUSTOMER STATED HIS BLOOD GLUCOSE WAS 202 MG/DL AND WHEN HE PUT THE INSULIN PUMP ON SUSPEND THE CUSTOMER WOKE UP WITH BLOOD GLUCOSE OF 46 MG/DL. THE CUSTOMER WAS FEELING LETHARGIC. THE CUSTOMER TREATED HIS BLOOD GLUCOSE BY MANUAL INJECTION. THE CURRENT BLOOD GLUCOSE READING IS 146 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318831 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR