BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 4906596 · Received July 10, 2015

    Report

    Report Number
    3004209178-2015-73494
    Event Type
    Death
    Date Received
    July 10, 2015
    Date of Event
    April 6, 2015
    Report Date
    October 22, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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 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.

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH A DEPLETED ENERGIZER ALKALINE BATTERY INSTALLED. DEVICE PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DELIVERY ACCURACY TEST AT 0.08720 INCHES. THE STOP (IDLE) CURRENT AND RUN CURRENT MEASUREMENT TESTS ARE WITHIN SPECIFICATION. DEVICE ALSO PASSED SELF TEST, OFF NO POWER ALARM TEST AND A21 ERROR TEST. DEVICE UPLOADED PROPERLY USING CARELINK. NO COSMETIC DAMAGE NOTED. DATA ANALYSIS: (DATE OF DEATH: (B)(6) 2015.) THERE IS NO DATA AVAILABLE DUE TO THE UNIT RECEIVED WITH A DEPLETED BATTERY INSTALLED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME. THE CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE. THE CUSTOMER HAD KIDNEY FAILURE, HEART FAILURE, AND DIABETES COMPLICATIONS (THE CALLER DID NOT SPECIFY). THE CUSTOMER'S BLOOD GLUCOSE, AT THE TIME OF DEATH, WAS 200 MG/DL. THIS WAS THE LAST RECORDED BLOOD GLUCOSE READING IN THE GLUCOSE METER, ON 04/06/2015 AT 11:00 AM. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS AND WAS NOT WEARING ONE AT THE TIME OF DEATH. THE CALLER STATED THAT THE INSULIN PUMP CANNOT BE RETURNED BECAUSE THE CORONER TOOK THE INSULIN PUMP AND IT IS CURRENTLY UNKNOWN WHERE THE DEVICE IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448965 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death