BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780K 670G 3ML BLACK

    MDR report key: 7849404 · Received September 5, 2018

    Report

    Report Number
    2032227-2018-23420
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    August 11, 2018
    Report Date
    September 5, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 400 MG/DL. CUSTOMER STATED THAT THEY ISSUE WITH SENSOR. TROUBLESHOOTING WAS PERFORMED. THE PRODUCT WILL NOT BE RETURNED FOR THE ANALYSIS. CONCOMITANT PRODUCT: OZO-MMT-7020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690369 PUMP MMT-1780K 670G 3ML BLACK ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780K HG29DW4 00643169939202

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other