BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 4110789 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27927
    Event Type
    Death
    Date Received
    September 23, 2014
    Date of Event
    September 14, 2014
    Report Date
    April 30, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY FAILURE ANALYSIS THAT WAS NOT INCLUDED ON THE INITIAL DEVICE EVALUATION: THE INSULIN PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY FROM CARDIAC ARREST. HER BLOOD GLUCOSE AT THE TIME WAS 199 MG/DL. LEADING UP TO THE CUSTOMER'S PASSING, SHE SUFFERED FROM STAGE 4 CHRONIC KIDNEY DISEASE AND HAD A FISTULA INSERTED IN HER ARM FOUR DAYS PRIOR, SO SHE COULD BEGIN DIALYSIS. THE CUSTOMER WAS HOSPITALIZED FOR FOUR DAYS WHEN THE FISTULA WAS INSERTED AND WAS RELEASED FROM THE HOSPITAL THE MORNING OF HER PASSING. SHE WAS ON THE INSULIN PUMP AT THE TIME OF PASSING. THE PATIENT'S HUSBAND ALSO MENTIONED THAT THE CUSTOMER HAD MULTIPLE PREVIOUS EMERGENCY ROOM VISITS FOR DIABETES-RELATED ISSUES, MOSTLY LOW BLOOD GLUCOSE, BUT THESE WERE DUE TO COMPLICATIONS FROM HER STAGE 4 CHRONIC KIDNEY DISEASE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589909 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAS A2551NASJ

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death