BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 4842258 · Received June 12, 2015

    Report

    Report Number
    3004209178-2015-65638
    Event Type
    Death
    Date Received
    June 12, 2015
    Date of Event
    May 7, 2015
    Report Date
    June 11, 2015
    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

    THE INSULIN PUMP WAS RETURNED WITH NO BATTERY IN THE BATTERY TUBE. THE INSULIN PUMP PASSED FUNCTIONAL TEST INCLUDING PRIME, DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS. THE INSULIN PUMP WAS RECEIVED WITH SLIGHTLY BENT BATTERY TUBE SPRING, MINOR SCRATCHES ON THE DISPLAY WINDOW, SLIGHTLY DENTED CASE AND SCRATCHED RESERVOIR TUBE WINDOW NOTED.

    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. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE 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

    THE SPOUSE REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2015 AT HOME. THE OFFICIAL CAUSE OF DEATH WAS FROM DIABETES AND CARDIOVASCULAR DISEASE. THE CUSTOMER'S BLOOD GLUCOSE WAS 20 MG/DL AT THE TIME OF DEATH. THE CALLER STATED THE CUSTOMER BECAME ILL ON THE NIGHT OF THEIR PASSING. THE CALLER REPORTED THE CUSTOMER WAS UNABLE TO GET OUT OF BED PRIOR TO THEIR DEATH. THE CALLER ATTEMPTED TO TREAT THE CUSTOMER WITH A CUBE OF GLUCOSE BEFORE THEIR PASSING. IT WAS REPORTED THE PARAMEDICS WERE CALLED, BUT THEY WERE UNABLE TO REVIVE THE CUSTOMER. IT WAS REPORTED THE CUSTOMER USED SENSORS AND WAS WEARING A SENSOR AT THE TIME OF DEATH. IT WAS ALSO REPORTED THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CALLER DECLINED TO RETURN THE INSULIN PUMP AT THE TIME OF THE CALL.

    Description of Event or Problem · 1

    THE NEXT OF CALLED BACK AFTER RECEIVING THE CALL BACK REQUEST LETTER. THE CALLER ALSO NOTED THAT SOMETHING WENT WRONG AS THE CUSTOMER PASSED AWAY DUE TO HAVING LOW BLOOD GLUCOSE, IN THE MIDDLE OF THE NIGHT. THE CUSTOMER HAD BEEN USING THE INSULIN PUMP FOR ONLY A FEW DAYS AND WAS UNDER THE IMPRESSION THAT THE INSULIN PUMP WAS SUPPOSED TO PREVENT HIM FROM GOING LOW. THE CALLER STATED THAT SHE DOES NOT WANT TO BE CONTACTED REGARDING THIS MATTER, ANYMORE. THE CALLER STATED THAT THE SHE DID NOT HAVE THE INSULIN PUMP; HER SON HAS IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386120 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death