BEUDAMED
    FDA Adverse Event Injury Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 12195700 · Received July 20, 2021

    Report

    Report Number
    2032227-2021-169988
    Event Type
    Injury
    Date Received
    July 20, 2021
    Date of Event
    October 1, 2020
    Report Date
    July 20, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT CUSTOMER HOSPITALIZED FOR HIGH BLOOD GLUCOSE ON (B)(6) 2020 DUE TO INSULIN PUMP FAILURE. BLOOD GLUCOSE READING WAS 600 MG/DL TO 700 MG/DL. THE CUSTOMER STATED THAT INSULIN PUMP WAS WORKING PROPERLY AND DECLINED TO TROUBLESHOOT FOR THE CUSTOMER¿S HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT AUTO MODE WAS ON AND OFF. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR, UNOMED INF SET, OZP-MMT-7020-SNSR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095392 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG44A7U 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR