BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 8825330 · Received July 25, 2019

    Report

    Report Number
    2032227-2019-35811
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    July 16, 2019
    Report Date
    September 20, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169656840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PASSED ALL FUNCTIONAL TESTS INCLUDING DISPLACEMENT, AND SELF TESTS. NO UNEXPECTED PUMP ERROR 15 OR UNEXPECTED RESTARTS OCCURRED DURING TESTING. (B)(4).

    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.

    Description of Event or Problem · 1

    THE CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PUMP ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS REBOOTING ON ITS OWN. CUSTOMER WAS ABLE TO CLEAR THE ALARM. CUSTOMER DECLINED TROUBLESHOOTING ANYMORE SINCE THEY BELIEVE THAT THE INSULIN PUMP WAS NOT WORKING AS EXPECTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619117 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG1SG97 00643169656840

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR