BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4242819 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-49909
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    NO FROZEN DISPLAY NOTED, TIME ADVANCES PROPERLY. NO UNEXPECTED BLANK DISPLAYS NOTED DURING TESTING. ALL BUTTONS FUNCTION PROPERLY. HOWEVER, INSULIN PUMP HAD MOISTURE DAMAGE ON KEYPAD TRACES. INSULIN PUMP PASSED DISPLACEMENT TEST AND OFF NO POWER TEST. THE OPERATING CURRENTS WERE IN SPECIFICATIONS. INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE ON LCD WINDOW CORNERS, BROKEN RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE, CRACKED BATTERY TUBE THREADS AND BROKEN BELT CLIP SLOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD AN UNRESPONSIVE KEYPAD. THE BLOOD GLUCOSE READING WAS 360 MG/DL. NO SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUES WERE OBSERVED. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726167 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 57 YR