BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3930873 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86870
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME TESTS AND EXCESSIVE NO DELIVERY TESTS. THE INSULIN PUMP POWER UP PROPERLY AFTER BATTERY INSTALLATION. THE INSULIN PUMP RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATION. THE INSULIN PUMP WAS MONITORED AND NO BLANK DISPLAY ANOMALIES WERE NOTED. NO DAMAGE ON THE CONNECTORS AND LCD ISOLATION TAPE NOTED. THE INSULIN PUMP RECEIVED WITH INTERMITTENT BUTTONS DUE TO TO CORRODED KEYPAD TRACES. NO DISPLAY RAMPING ON IT'S OWN NOTED. THE INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS AND MINOR SCRATCHES ON DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SCREEN ON THE INSULIN PUMP WENT BLANK TWICE WHEN SETTING UP RESERVOIR. CUSTOMER ALSO STATED THAT THE BUTTONS ON THE INSULIN PUMP ARE UNRESPONSIVE. CUSTOMER STATED THAT THE NUMBERS KEPT CHANGING DURING FIXED PRIME. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 39 MG/DL AND HAS TREATED WITH FOOD. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408604 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR