BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754DAS

    MDR report key: 8806025 · Received July 19, 2019

    Report

    Report Number
    2032227-2019-32367
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    July 5, 2019
    Report Date
    October 1, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169535749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED COMPLETELY DESTROYED. DEVICE HAD CRACKED AND BROKEN OFF END CAP, CRACKED RESERVOIR TUBE, TORN KEYPAD OVERLAY, DAMAGE MOTOR HOUSING, DAMAGE ELECTRONIC ASSEMBLY AND CRACKED AND BLEEDING LCD GLASS. UNABLE TO PERFORM THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DELIVERY ACCURACY TEST, THE STOP (IDLE) CURRENT AND RUN CURRENT MEASUREMENT TESTS, SELF TEST, OFF NO POWER ALARM TEST AND A21 ERROR TEST OR TEST FOR UNEXPECTED NO DELIVERY ALARM DUE TO PHYSICAL DAMAGE TO THE PUMP. UNABLE TO TEST FOR BLANK DISPLAY DUE TO PHYSICAL DAMAGE TO THE INSULIN PUMP. UNABLE TO PERFORM THE PUMP TRACE HISTORY DOWNLOAD OR UPLOADED PROPERLY USING CARELINK DUE TO PHYSICAL DAMAGE TO THE PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 84 MG/DL AND 500 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE BOTTOM PART OF INSULIN PUMP WAS BROKE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603099 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754DAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754DAS A9754DASJ 00643169535749

    Patients

    Seq Age Sex Outcome Treatment
    1