BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP MMT-751NAP

    MDR report key: 8472248 · Received April 2, 2019

    Report

    Report Number
    3004209178-2019-75432
    Event Type
    Injury
    Date Received
    April 2, 2019
    Date of Event
    March 25, 2019
    Report Date
    April 1, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS (B)(6) 2019 AT 5 AM WITH BLOOD GLUCOSE OF 574 MG/DL. THE CUSTOMER'S OTHER BLOOD GLUCOSE WAS 160, 595 MG/DL. THE CUSTOMER WAS TREATED WITH INTRAVENOUS FLUID AND INTRAVENOUS FLUID. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269329 530G INSULIN PUMP MMT-751NAP ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP A4751NAPJ 00643169503700

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization UNOMEDICAL SET, FRN-UNKNOWN-RSVR