BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 3903532 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-86331
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY. THE LAST BLOOD GLUCOSE RECORDED IN THE BLOOD GLUCOSE METER WAS UNKNOWN. IT WAS STATED THAT THE CUSTOMER HAD INFECTION THAT CAUSE HER KIDNEYS TO FAIL AND CONTRACTED PNEUMONIA. THE CALLER WAS UNSURE IF THE CUSTOMER WAS WEARING THE INSULIN PUMP AT TIME OF DEATH. ADVISED THE CALLER TO HAVE A FUNCTIONING BATTERY LEFT IN THE INSULIN PUMP, OTHERWISE CRITICAL DATA MAY BE LOST. ATTEMPTED TO CONTACT A CUSTOMER'S FAMILY AND THE SPOUSE STATED THAT THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT TIME OF PASSING. THE SPOUSE STATED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE OF 60MG/DL. THE CUSTOMER DID ATTEMPT TO PUT IT BACK ON, BUT SHE WAS DELIRIOUS AND HE TOOK THE DEVICE BACK OFF OF HER. THE SPOUSE STATED THAT THE CUSTOMER HAD LOWS BECAUSE SHE WAS NOT EATING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379166 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death