BEUDAMED
    FDA Adverse Event Injury Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 11737637 · Received April 28, 2021

    Report

    Report Number
    2032227-2021-140198
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    April 25, 2021
    Report Date
    April 28, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 52 MG/DL. CUSTOMER DECLINED THE TROUBLESHOOTING FOR LOW BLOOD GLUCOSE. CUSTOMER STATED THAT THEY PUP ON SENSOR BUT TAPE NOT STICKING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638136 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4J3S4 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other FRN-UNK-RSVR, UNOMED INF SET, OZP-MMT-SNSR