BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWB

    MDR report key: 8665240 · Received June 3, 2019

    Report

    Report Number
    2032227-2019-10741
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    March 19, 2019
    Report Date
    June 3, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00613994858528
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STOP (IDLE) CURRENT AND RUN CURRENT MEASUREMENT TESTS ARE WITHIN SPECIFICATION. UNIT ALSO PASSED SELF TEST AND THE OFF NO POWER ALARM TEST. UNIT RECEIVED WITH A BROKEN OFF MOTOR SLIDE TIP. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/COMPROMISED FORCE SENSOR SYSTEM TEST, EXCESSIVE NO DELIVERY TEST AND DELIVERY ACCURACY TEST DUE TO BROKEN OFF MOTOR SLIDE TIP. UNABLE TO TEST FOR NO DELIVERY ALARM OR MOTOR ERROR ALARM DUE TO BROKEN OFF MOTOR SLIDE TIP. THE MOTOR WAS TESTED OUTSIDE OF THE UNIT AND PASSED. UNIT UPLOADED PROPERLY USING CARELINK. UNIT ALSO HAD MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, BROKEN BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE LIP AND A STAINED END CAP STICKER. 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

    CUSTOMER CALLED AND REPORTED THAT THEY GOT HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 500 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 228 MG/DL ON THE MORNING OF THE CALL. THE CUSTOMER DID NOT MENTION HOW THEY WERE TREATED. THE CUSTOMER EXPERIENCED DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458536 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWB PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWB 00613994858528

    Patients

    Seq Age Sex Outcome Treatment
    1