BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4223430 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46991
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    July 5, 2014
    Report Date
    October 5, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED FAILED BATTERY TEST, DUE TO CORRODED BATTERY TUBE AND BATTERY CAP CONTACT. INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTONS, DUE TO CORRODED KEYPAD TRACES. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAD A NONRESPONSIVE KEYPAD. THE CUSTOMER ALSO HAD MULTIPLE FAILED BATTERY TESTS. THE CUSTOMER'S BLOOD GLUCOSE LEVELS ARE UNKNOWN. STANDARD TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE PRODUCT HAS BEEN RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707578 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR