BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711P

    MDR report key: 7180681 · Received January 10, 2018

    Report

    Report Number
    3004209178-2018-42405
    Event Type
    Malfunction
    Date Received
    January 10, 2018
    Date of Event
    December 27, 2017
    Report Date
    September 27, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169554948
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G 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

    UNIT WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATION AND PASSED SELF-TEST AND DISPLACEMENT TEST. UNIT WAS RECEIVED WITH ALL BUTTONS RESPONDING PROPERLY. NO DAMAGE OR MOISTURE DAMAGE ON KEYPAD ASSEMBLY. NO UNLOCKED KEYPAD CONNECTOR. NO STUCK BUTTON ALARMS OR KEYPAD ANOMALIES NOTED. UNIT WAS RECEIVED WITH CRACKED CASE ON THE BACK AT THE BATTERY TUBE AREA AND BATTERY TUBE THREADS. UNIT WAS RECEIVED WITH CRACKED KEYPAD OVERLAY AT SELECT BUTTON. UNIT WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CASE AND KEYPAD OVERLAY TEXTURE DAMAGED. FORMATTED HISTORY FILE ANALYSIS CONFIRMED PUMP ERROR 53 AND PUMP ERROR 4 DUE TO SOFTWARE ERROR (TT 2252). TRACES OF MOISTURE WERE FOUND AT THE ELECTRONIC AND MOTOR ASSEMBLIES PER VISUAL INSPECTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS 7.4 MMOL/L AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP UP BUTTON WAS UNRESPONSIVE. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. CUSTOMER ALSO REPORTED CRACK ON THE INSULIN PUMP RESERVOIR COMPARTMENT. CUSTOMER HAD A PUMP ERROR ALARM AS WELL. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24464 640G INSULIN PUMP MMT-1711P PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711P HG0HM9B 00643169554948

    Patients

    Seq Age Sex Outcome Treatment
    1