BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP MMT-1715KR 630G

    MDR report key: 13050246 · Received December 21, 2021

    Report

    Report Number
    2032227-2021-232691
    Event Type
    Injury
    Date Received
    December 21, 2021
    Date of Event
    December 10, 2021
    Report Date
    December 20, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000173036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD EXPERIENCED HYPERGLYCEMIA. THE BLOOD GLUCOSE LEVEL WAS 450 MG/DL. THE CUSTOMER DECLINED OR UNABLE TO PERFORMED TROUBLESHOOT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. FRN-MMT-332A-RSVR, UNOMED SET, OZO-MMT-7020A-SNSR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1954048 630G INSULIN PUMP MMT-1715KR 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KR HG32WD4 000000763000173036

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male