BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANIMAS VIBE SYSTEM

    MDR report key: 5447785 · Received February 19, 2016

    Report

    Report Number
    3004753838-2016-25352
    Event Type
    Death
    Date Received
    February 19, 2016
    Date of Event
    December 28, 2015
    Report Date
    January 26, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DESCRIBE EVENT OR PROBLEM - ADDITIONAL. DEVICE AVAILABLE FOR EVALUATION - ADDITIONAL. INITIAL REPORTER INFORMATION - CORRECTION. CORRECTION/ADDITIONAL INFORMATION/DEVICE EVALUATION. DEVICE EVALUATED BY MANUFACTURER - ADDITIONAL. EVENT PROBLEM AND EVALUATION CODES - ADDITIONAL.

    Description of Event or Problem · 1

    PATIENT'S WIFE CONTACTED DEXCOM ON (B)(6) 2016, TO REPORT A PATIENT DEATH THAT OCCURRED ON (B)(6) 2015. PATIENT'S WIFE REPORTED THAT THE PATIENT HAD BEEN HOOKED UP TO A MACHINE SINCE AROUND (B)(6) 2015. PATIENT'S WIFE REPORTED THAT THE PATIENT HAD MANY HEALTH ISSUES, AND MENTIONED NEUROPATHY OF THE LEGS. PATIENT'S WIFE STATED THAT THE PATIENT WAS ASLEEP AND NEVER WOKE UP. PATIENT WAS NOT WEARING DEXCOM EQUIPMENT AT THE TIME OF DEATH. PATIENT WAS WEARING HIS ANIMAS VIBE INSULIN PUMP. PATIENT'S WIFE CALLED EMERGENCY MEDICAL TECHNICIAN'S (EMT) AT THE TIME OF THE REPORTED EVENT. PATIENT WAS PRONOUNCED DEAD AT THE SCENE. PATIENT WAS NOT TRANSPORTED TO THE HOSPITAL. PATIENT'S WIFE REPORTED THAT THE PATIENT'S CAUSE OF DEATH WAS CIRRHOSIS OF THE LIVER AND A BREATHING/LUNG ISSUE, BUT COULD NOT RECALL EXACTLY. IT WAS FURTHER STATED THAT THE PATIENT TOOK SEVERAL MEDICATIONS, BUT DID NOT PROVIDE DETAILS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THERE WAS NO ALLEGED DEVICE MALFUNCTION. A CERTIFICATE OF DEATH WAS PROVIDED, CONFIRMING PATIENT EXPIRED AS A RESULT OF LIVER CIRRHOSIS AND ASPIRATION. IT SHOULD BE NOTED THAT DIABETES MELLITUS IS A KNOWN CAUSE OF DEATH RELATED TO COMPLICATIONS OF THE DISEASE.

    Description of Event or Problem · 1

    THE COMPLAINT STATES THAT ON (B)(6) 2016, THE PATIENT'S WIFE CONTACT DEXCOM AND REPORTED THE PATIENT PASSED AWAY ON (B)(6) 2015. THE PATIENT'S WIFE REPORTED THE PATIENT HAD MANY HEALTH ISSUES. ALTHOUGH IT WAS REPORTED THAT THE PATIENT'S DEATH WAS NOT CGM RELATED AND THERE WERE WAS NO ALLEGED DEVICE MALFUNCTION; A TRANSMITTER (PART NUMBER STT-GL-003/ LOT NUMBER 5203369/ SERIAL NUMBER (B)(4)) WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED FAULT COULD NOT BE REPRODUCED AND THERE WAS NO FAILURE DETECTED. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104040 ANIMAS VIBE SYSTEM OYC OYC DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death| O