BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 6334156 · Received February 15, 2017

    Report

    Report Number
    3004209178-2017-90882
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    December 8, 2016
    Report Date
    February 8, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: UNIT RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE ELECTRONIC ASSEMBLY. UNABLE TO PERFORMED FUNCTIONAL TEST DUE TO BLANK DISPLAY. UNABLE TO VERIFY MOTOR ERROR ALARM DUE TO BLANK DISPLAY ANOMALY. UNIT HAD MINOR SCRATCHED LCD WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND CRACKED LCD WINDOW. DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. UNABLE TO VERIFY E70 ALARM DUE TO BLANK DISPLAY ANOMALY. JR (B)(6) 2017 THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING BOLUS AND BASAL DELIVERY. THE PATIENT'S BLOOD GLUCOSE AT THE TIME OF INCIDENT IS UNKNOWN. DURING TROUBLESHOOTING THE INSULIN PUMP WAS ABLE TO REWIND. THE DEVICE ALSO PASSED THE DISPLACEMENT TEST. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114428 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWB

    Patients

    Seq Age Sex Outcome Treatment
    1