BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6158383 · Received December 9, 2016

    Report

    Report Number
    2032227-2016-48704
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 24, 2016
    Report Date
    November 24, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM DURING TESTING NOTED. UNABLE TO PERFORM ALL CURRENTS, UNEXPECTED RESTART ERROR TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/DELIVERY AND EXCESSIVE NO DELIVERY TEST OR VERIFY WEAK BATTERY ALARM, FAILED BATTERY TEST ALERT AND BATTERY OUT LIMIT ALARM DUE TO BUTTONS NOT RESPONDING. NO NUMBERS SCROLLING AND NO FROZEN DISPLAY DURING TESTING NOTED. PUMP RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW AND CRACKED BATTERY TUBE THREADS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL THAT NUMBERS ON DISPLAY SCREEN BEGAN TO SCROLL WITHOUT PROMP AS CUSTOMER WAS ATTEMPTING TO BOLUS. AFTER CUSTOMER CHANGED BATTERY, INSULIN PUMP RECEIVED A WEAK BATTERY ALERT AND A BATTERY OUT LIMIT ALARM. IT WAS REPORTED THAT ALARM DID NOT STOP AFTER TROUBLESHOOTING. INSULIN PUMP WOULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815184 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR