BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5222172 · Received November 13, 2015

    Report

    Report Number
    2032227-2015-65621
    Event Type
    Malfunction
    Date Received
    November 13, 2015
    Date of Event
    October 28, 2015
    Report Date
    October 28, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT PASSED THE REWIND BASIC OCCLUSION TEST, PRIME/DELIVERY TEST AND DISPLACEMENT TEST. HOWEVER, UNIT RECEIVED STUCK IN THE MOTOR ERROR LOOP DURING BOLUS / BASAL DELIVERY AND MOTOR POSITION ENCODER ERROR ALARM CONFIRMED IN THE HISTORY FILE. THE MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. NO UNEXPECTED CHECK SETTING ALARMS OR PUMPS RESETTING ANOMALY NOTED. UNABLE TO PERFORM UNEXPECTED RESTART ALARM ERROR TEST DUE TO MOTOR ERROR ALARMS. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, RESERVOIR TUBE LIP AND BATTERY TUBE THREADS. UNIT RECEIVED WITH MINOR SCRATCHED LCD WINDOW. UNIT RECEIVED WITH STAINED END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL TO HAVE RECEIVED A MOTOR ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 154 MG/DL. DURING TROUBLESHOOTING, IT WAS FOUND THAT CUSTOMER ALSO RECEIVED A MOTOR POSITION ENCODER ERROR ALARM. AFTER TROUBLESHOOTING, CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753474 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR