BEUDAMED
    FDA Adverse Event Death Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 14082564 · Received April 12, 2022

    Report

    Report Number
    2032227-2022-178461
    Event Type
    Death
    Date Received
    April 12, 2022
    Date of Event
    February 23, 2022
    Report Date
    April 12, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000316631
    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 CAUSE OF DEATH WAS SUDDEN OVERDOSE. THE CALLER STATED THAT THE CUSTOMER DID NOT HAD UNDERLYING CONDITION THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. CUSTOMER STATED INSULIN PUMP WAS WORN AT THE TIME OF INCIDENT. IT WAS UNKNOWN IF THE CALLER WILL RETURN THE INSULIN PUMP FOR ANALYSIS. FRN-MMT-332-RSVR, UNOMED INF SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211571 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG3YE6Q 000000763000316631

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Death