BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4112181 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27581
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THE ERROR ALARM. BLOOD GLUCOSE LEVEL WAS 180 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591514 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1