BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 6086471 · Received November 8, 2016

    Report

    Report Number
    2032227-2016-40062
    Event Type
    Death
    Date Received
    November 8, 2016
    Date of Event
    October 27, 2016
    Report Date
    November 2, 2016
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME. THE OFFICIAL CAUSE OF DEATH WAS CARDIAC ARRHYTHMIA DUE TO RENAL FAILURE AND DIABETES. THE CALLER STATED THAT THEY BELIEVE THE CAUSE OF DEATH WAS EITHER LOW BLOOD GLUCOSE OR HEART ATTACK. THE CUSTOMER HAD KIDNEY FAILURE, HEART DISEASE AND DIABETES COMPLICATIONS. THE CALLER STATED THAT THE CUSTOMER HAD AN OPEN HEART SURGERY IN (B)(6). THE CALLER DID NOT KNOW THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF DEATH. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737077 530G INSULIN PUMP OZO OZO MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death