BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP MMT-751NAS

    MDR report key: 8068401 · Received November 14, 2018

    Report

    Report Number
    2032227-2018-60594
    Event Type
    Death
    Date Received
    November 14, 2018
    Date of Event
    October 27, 2018
    Report Date
    November 14, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169404342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2018 DUE TO CARDIAC ARREST AND POTASSIUM ISSUES. THE CAUSE OF DEATH WAS DIABETIC KETOACIDOSIS. THE CALLER STATED THAT THE CUSTOMER HAD CARDIAC ISSUES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS 1550 MG/DL AT THE TIME OF HOSPITALIZATION. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. FRN-MMT-332-RSVR. UNOMED SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912151 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS A2751NASJ 00643169404342

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Death