BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4150357 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-35059
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    August 18, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY. CUSTOMER STATED SHE CAN CLEAR THE ALARM BUT IT KEPT COMING BACK. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 144 MG/DL. CUSTOMER AT WORK AND CANNOT CHANGE OUT THE SET. CUSTOMER UNABLE TO TROUBLESHOOT. CUSTOMER STATED THAT WHEN SHE REWIND THE INSULIN PUMP WORKS FINE. CUSTOMER DOES NOT WANT TO RETURN THE SET AND RESERVOIR FOR ANALYSIS. ADVISED TO CALL BACK WHEN THE ALARM OCCURS IN ORDER TO TROUBLESHOOT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629834 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR