BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4153727 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-35759
    Event Type
    Death
    Date Received
    October 8, 2014
    Date of Event
    September 21, 2014
    Report Date
    December 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    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.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    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.

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED THAT CUSTOMER PASSED AWAY ON (B)(6) 2014. CUSTOMER'S WIFE WAS UNSURE OF CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF DEATH, BUT SHE SAID IT RAN FROM 200 MG/DL TO 600 MG/DL. LEADING UP TO CUSTOMER'S PASSING, HIS POTASSIUM WAS REALLY HIGH AND HE MISSED A DIALYSIS. THERE WERE SEVERAL FACTORS THAT CAUSED CUSTOMER'S DEATH, SO CUSTOMER'S WIFE IS WAITING FOR THE DEATH REPORT. CUSTOMER WAS NOT WEARING THE DEVICE WHEN HE PASSED AWAY BECAUSE THE HOSPITAL STAFF HAD TAKEN IT OFF TO TREAT HIM. THE DEVICE IS BEING SENT BACK FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631760 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death