BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4212012 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-45052
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ACT BUTTON DID NOT RESPOND, DUE TO FLATTENED BUTTON DOME SWITCH. UNABLE TO PERFORM DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST, DUE TO NO BUTTON RESPONSE. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNRESPONSIVE KEYPAD. SHE ALSO REPORTED THERE WAS A FULL CIRCLE ON HER INSULIN PUMP'S SCREEN. THE CUSTOMER'S BLOOD GLUCOSE WAS 375 MG/DL. TROUBLESHOOTING FOR THE CUSTOMER'S HIGH BLOOD GLUCOSE COULD NOT OCCUR BECAUSE THE KEYPAD WAS NOT RESPONDING. SHE ALSO STATED SHE BELIEVED HER HIGH BLOOD GLUCOSE WAS FROM HER INSULIN NOT WORKING. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693193 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 59 YR