BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4131880 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31268
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 30, 2014
    Report Date
    December 23, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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. 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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NO UP BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE INSULIN HAD MINOR SCRATCHED LCD WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP AND STAINED END CAP STICKER.

    Description of Event or Problem · 1

    THE IT WAS REPORTED THAT THE BUTTONS ON THE CUSTOMER'S INSULIN PUMP WERE NOT RESPONDING DURING A BOLUS DELIVERY ATTEMPT. HER BLOOD GLUCOSE LEVEL WAS 173 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611867 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR