BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3970035 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88397
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP MONITORED IN 50C OVEN FOR SEVERAL DAYS AND NO FAILED BATTERY TEST, BLANK DISPLAY, CONSTANT TONE OR UNEXPECTED BLACK CIRCLE ANOMALY NOTED. INSULIN PUMP RECEIVED WITH NORMAL OPERATING CURRENTS. NO DAMAGE FOUND ON THE CONNECTOR INTERFACE BOARD ISOLATION TAPE NOTED. INSULIN PUMP HAD AN INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE KEYPAD TRACES. INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHES ON DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD AN ISSUE WITH ITS KEYPAD. THE BLOOD GLUCOSE READING WAS 136 MG/DL. THE CUSTOMER STATED THAT HER INSULIN PUMP HAD STOPPED WORKING AND THAT SHE HAD ALREADY DONE ALL THE TROUBLESHOOTING TO NO AVAIL. THE KEYBOARD WAS REPORTED TO CONTINUE SCROLLING AFTER SHE HAD PUSHED THE UP BUTTON, EVEN AFTER SHE HAD RELEASED THE BUTTON. THE CUSTOMER OBSERVED THAT IT HAD BEEN HOT WHERE SHE LIVES AND THAT, AS A RESULT, THE INSULIN PUMP MAY HAVE BEEN EXPOSED TO POSSIBLE HUMIDITY AND PERSPIRATION. SHE ALSO NOTED THAT SHE RECEIVED A BATTERY TEST FAILED ALERT UPON REMOVAL OF THE DEVICE'S BATTERY. THE SCREEN WENT BLANK WITH ONLY A BLACK CIRCLE ON THE DISPLAY, AND THE DEVICE ALARMED WITH A LOUD SIREN. ADVISED THE DISCONTINUATION AND REPLACEMENT OF THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446837 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR