BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 8845160 · Received July 31, 2019

    Report

    Report Number
    2032227-2019-38938
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 22, 2019
    Report Date
    October 3, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00763000068998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 PASSED SELF TEST AND DISPLACEMENT TEST. DEVICE RECEIVED WITH THE AUDIO ALERT FUNCTIONING PROPERLY. NO AUDIO ALERT ANOMALY NOTED. PUMP ERROR 63 ALARM CONFIRMED IN THE INSULIN PUMP HISTORY DUE TO BROKEN PIN 6 TRACE (SDA) ON KEYPAD ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AN AUDIO ANOMALY. THE DEVICE WAS NOT MAKING ANY SOUND WHEN ALARMING. THE DEVICE ALARMED HARDWARE LOW LEVEL FAILURE DURING SELF-TEST. THE CUSTOMER¿S BLOOD GLUCOSE DURING THE INCIDENT WAS 14.4 MMOL/L. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642720 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K HG2CSM7 00763000068998

    Patients

    Seq Age Sex Outcome Treatment
    1