BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 13947020 · Received March 30, 2022

    Report

    Report Number
    2032227-2022-173626
    Event Type
    Injury
    Date Received
    March 30, 2022
    Date of Event
    March 24, 2022
    Report Date
    March 30, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000439866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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 · 0

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CURRENT BLOOD GLUCOSE LEVEL WAS 400 MG/DL. IT WAS UNKNOWN WHETHER CUSTOMER WAS USING THE AUTO MODE FEATURE. THE CUSTOMER DECLINED TO TROUBLESHOOT. NO FURTHER PATIENT COMPLICATION WERE REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR, FRN-UNOMED SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2730207 PUMP MMT-1880L MM770G BLE MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L HG5RHX3 000000763000439866

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female