BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4040920 · Received August 27, 2014

    Report

    Report Number
    2032227-2014-11284
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS PROGRAMMED WITH MULTIPLE BOLUSES AND MONITORED. ALL BOLUSES DELIVERED PROPERLY AND WERE LISTED IN THE BOLUS HISTORY SCREEN. NO BOLUS ANOMALY NOTED. THE DEVICE PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, SELF TEST AND OTHER ERROR TESTS. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. OFF NO POWER ALARM FUNCTIONS PROPERLY. ALL BUTTONS FUNCTION PROPERLY. NO DAMAGE NOTED ON KEYPAD TRACES. THE DEVICE WAS UNABLE TO BE PRIMED DURING PRIME TEST DUE TO FAULTY FORCE SENSOR RESISTOR. UNABLE TO PERFORM THE OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST DUE TO PRIME/FILL ANOMALY. INSPECTED THE KEYPAD FLEX CONNECTOR ON THE LCD, WHICH WAS LOCKED. THE DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED. THEY WERE REPORTING THAT THE INSULIN PUMP HAD UNRESPONSIVE KEYPAD. THE CUSTOMER'S BLOOD GLUCOSE WAS 26 MG/DL. THE DISCONTINUATION OF THE INSULIN PUMP WAS ADVISED. THE CUSTOMER STATED THAT THEY DO NOT HAVE A BACK-UP PLAN SO THEY WILL STILL USE THE INSULIN PUMP AND WILL MONITOR IT CLOSELY. THE CUSTOMER WAS ADVISED AGAINST DOING SO. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519227 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization