BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP MMT-751NAS

    MDR report key: 12484604 · Received September 16, 2021

    Report

    Report Number
    2032227-2021-194008
    Event Type
    Injury
    Date Received
    September 16, 2021
    Date of Event
    September 6, 2021
    Report Date
    September 16, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000643169404342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED FOR DIABETIC KETOACIDOSIS ON (B)(6) 2021. BLOOD GLUCOSE READING WAS 387 MG/DL AT TIME OF HOSPITALIZATION. CUSTOMER HAD A VOMITING SYMPTOMS. CUSTOMER WAS TREATED WITH INTRAVENOUS INSULIN DRIP FOR DIABETIC KETOACIDOSIS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR, UNOMED INF FRN-SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380310 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS A3751NASJ 000000643169404342

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR