BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 8883027 · Received August 12, 2019

    Report

    Report Number
    2032227-2019-45428
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    August 6, 2019
    Report Date
    October 24, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00763000068998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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. 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

    DEVICE WAS RECEIVED WITH A CRITICAL PUMP ERROR ALARM DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. UNABLE TO PERFORM THE SELF TEST, DISPLACEMENT TEST, REWIND TEST, PRIME OR SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, AND ACTIVE CURRENT MEASUREMENT TEST DUE TO CRITICAL PUMP ERROR ALARM. MOISTURE DAMAGE WAS ALSO FOUND ON THE MOTOR AND FORCE SENSOR DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD A CRITICAL PUMP ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 6.7 MMOL/L AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS IN THE HOT TUB, THEY NOTICED CRACK ON BACK OF THE INSULIN PUMP WHEN IT STOPPED WORKING. THE CUSTOMER STATED THAT THEY RECEIVED AN OPEN BOOK IMAGE ON THE INSULIN PUMP SCREEN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679092 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K HG2LK3K 00763000068998

    Patients

    Seq Age Sex Outcome Treatment
    1