BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240592 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49776
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP HAD NO MOISTURE DAMAGE ON ELECTRONIC, MOTOR, VIBRATOR KEYPADS AND BATTERY TUBE ASSEMBLY DURING VISUAL INSPECTION. NO LEAK FROM RESERVOIR NOTED. INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW AND STAINED END CAP STICKER.

    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. PLEASE SEE MEDWATCH REPORT 2032227-2014-49642.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS MOISTURE IN THE RESREVOIR COMPARTMENT OF THE INSULIN PUMP, DUE TO A LEAK IN THE RESERVOIR. THE CUSTOMER'S BLOOD GLUCOSE WAS 200 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723317 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR