BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP MMT-751NAS

    MDR report key: 6621926 · Received June 8, 2017

    Report

    Report Number
    3004209178-2017-53657
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    May 18, 2017
    Report Date
    June 8, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503717
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

    CUSTOMER'S DOCTOR REPORTED VIA PHONE CALL, THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 400 MG/DL. CUSTOMER'S DOCTOR DID NOT PROVIDE ANY FURTHER INFORMATION AS CUSTOMER'S DOCTOR DID NOT HAVE THE PRODUCT SERIAL NUMBER. CUSTOMER'S DOCTOR STATED THEY WOULD CALL BACK. CUSTOMER'S DOCTOR CALLED BACK ONLY TO NOTIFY THE CUSTOMER WAS TAKEN OFF THE INSULIN PUMP FOR THE NIGHT. THE INSULIN PUMP IS NOT RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404287 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS A4751NASJ 00643169503717

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization