BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8553955 · Received April 26, 2019

    Report

    Report Number
    3004209178-2019-88582
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    April 19, 2019
    Report Date
    June 27, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169656840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). PUMP ERROR 63 CONFIRMED IN THE SELF TEST AND THE DOWNLOADED HISTORY LOG DUE TO A PIO (SOFTWARE) FAILURE. PUMP ERROR 43 NOT CONFIRMED DURING TESTING. DEVICE FAILED THE SELF TEST AND PASSED THE DISPLACEMENT TEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 200 MG/DL AT THE TIME OF THE INCIDENT. ASSISTED WITH PERFORMING A SELF TEST AND SELF TEST WAS FAILED. CUSTOMER WAS ABLE TO COMPLETE REWIND. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346879 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG27SFU 00643169656840

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR