BEUDAMED
    FDA Adverse Event Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4131878 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31267
    Date Received
    October 1, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH BUTTON ERROR ALARM AND HAD NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. UNABLE TO PERFORMED DISPLACEMENT TEST DUE TO NO BUTTON RESPONSE. INSULIN PUMP WAS UNABLE TO PERFORMED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, EXCESSIVE NO DELIVERY, AND PRIME TESTS DUE TO NO BUTTON RESPONSE. INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHED LCD WINDOW, 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.(B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NUMBERS ON THE INSULIN PUMP WERE SCROLLING ON THEIR OWN AND THE BUTTONS WERE NOT WORKING WHEN HE ATTEMPTED TO DELIVER A BOLUS. THE CUSTOMER STATED THE TIME AND SCREEN WERE BLINKING AND COUNTING BACKWARDS. HE THEN RECEIVED A BUTTON ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 298 MG/DL, WHICH HE STATED HE WOULD TREAT WITH A BACK-UP PLAN. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE FOUND. 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
    610508 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR