BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP MMT-551NAP

    MDR report key: 14132492 · Received April 17, 2022

    Report

    Report Number
    2032227-2022-179774
    Event Type
    Death
    Date Received
    April 17, 2022
    Date of Event
    March 11, 2022
    Report Date
    April 17, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000643169503656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY AT HOME. THE CALLER STATED THAT THE CAUSE OF DEATH IS STILL UNKNOWN. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. FRN-MMT-332-RSVR, UNOMED INF SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907254 530G INSULIN PUMP MMT-551NAP ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP A4551NAPJ 000000643169503656

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Death