BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8665630 · Received June 4, 2019

    Report

    Report Number
    2032227-2019-11050
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 26, 2019
    Report Date
    July 21, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00763000090197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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.

    Additional Manufacturer Narrative · 1

    DEVICE PASSED DISPLACEMENT TEST AND SELFTEST. PUMP ERROR 63 WAS PRESENT IN THE DEVICE TRACE DOWNLOAD DUE TO BROKEN TRACE AT PIN 6 ON KEYPAD ASSEMBLY. TOGGLED ON AND INCREASED VOLUME WITH THE AUDIO FEATURE FUNCTIONING PROPERLY. NO AUDIO OR ABSENCE OF ALARM ANOMALIES NOTED DURING TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AN AUDIO ANOMALY. THE DEVICE FAILED THE AUDIO TEST DURING THE CALL. THE CUSTOMER¿S BLOOD GLUCOSE DURING THE INCIDENT WAS UNKNOWN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461800 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG2MVPJ 00763000090197

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR