BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6018720 · Received October 11, 2016

    Report

    Report Number
    2032227-2016-29146
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 19, 2016
    Report Date
    November 10, 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

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY. THE MOISTURE DAMAGE WAS FOUND ON MOTOR ASSEMBLY. WE WERE UNABLE TO VERIFY FOR COUNTING UP NUMBER ANOMALY, BLACK SCREEN AND UNABLE TO PERFORM FUNCTIONAL CHECK INCLUDING REWIND AND BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY, DISPLACEMENT, SELF-TEST, UNEXPECTED RESTART TEST AND ALL OPERATING CURRENT MEASUREMENT DUE TO BLANK DISPLAY. THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY ANOMALY. THE PATIENT'S BLOOD GLUCOSE AT THE TIME OF INCIDENT IS UNKNOWN. TROUBLESHOOTING WAS INITIATED FOR THE BLANK DISPLAY. THE CUSTOMER CONFIRMED THAT THE INSULIN PUMP WAS NOT BUMPED, DROPPED, OR EXPOSED TO MOISTURE. THE CUSTOMER ALSO CONFIRMED THAT THE BATTERY CAP CONTACTS, BATTERY COMPARTMENT, AND SPRING DID NOT HAVE ANY DAMAGE, CORROSION, OR MISSING COMPONENTS. A NEW ALKALINE AAA BATTERY WAS INSERTED INTO THE INSULIN PUMP BUT THE DISPLAY DID NOT RETURN. THE BATTERY CAP CONTACT WAS CLEANED AND A NEW AAA ALKALINE BATTERY WAS INSERTED AGAIN: THE DISPLAY RETURNED AND THEN WENT BLANK AGAIN. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS AND A REPLACEMENT DEVICE WAS SHIPPED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670387 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR