BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLUCOMMANDER

    MDR report key: 7630431 · Received June 22, 2018

    Report

    Report Number
    3005853093-2018-00002
    Event Type
    Death
    Date Received
    June 22, 2018
    Date of Event
    May 31, 2018
    Report Date
    June 22, 2018
    Manufacturer
    GLYTEC, LLC
    Product Code
    NDC
    UDI-DI
    00860057000305
    PMA / PMN Number
    K152300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO CUSTOMER REPORTS, THE FINAL THREE BGS WERE TAKEN FROM A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) WHICH HAD DEXTROSE INFUSING THROUGH ONE OF THE PORTS AND THE CONTAMINATED SAMPLES RESULTED IN FALSELY ELEVATED POC BLOOD GLUCOSE MEASUREMENTS. APPLICATION AUDIT LOGS FOR THIS PATIENT TREATMENT WERE REVIEWED, ENCOMPASSING COMPONENTS SUCH AS SETTINGS AND CONFIGURATION, SENSITIVITY FACTOR ADJUSTMENTS, INSULIN INFUSION RATE RECOMMENDATIONS, WARNINGS AND ALERTS. A SIMULATION CASE WAS ALSO EVALUATED IN A TEST ENVIRONMENT AND PRODUCED IDENTICAL RESULTS. AFTER CAREFUL REVIEW AND DIAGNOSTIC TESTING, IT WAS DETERMINED THAT THE APPLICATION PERFORMED WITHIN SPECIFICATIONS AND NO PRODUCT NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A CRITICALLY ILL HOSPITALIZED PATIENT, WAS STARTED ON GLUCOMMANDER IV. THE PATIENT REACHED TARGET RANGE AND REMAINED IN TARGET FOR APPROXIMATELY 8 HOURS, UPON WHICH A BLOOD GLUCOSE OF 292 MG/DL WAS ENTERED BY THE NURSE. BECAUSE OF THE DRAMATIC CHANGE IN BLOOD GLUCOSE LEVELS, GLUCOMMANDER PRESENTED A WARNING TO THE END USER ALERTING THEM THAT THIS BLOOD GLUCOSE WAS SIGNIFICANTLY HIGHER THAN THE PREVIOUS BLOOD GLUCOSE AND ASKING THEM TO CONFIRM THE BLOOD GLUCOSE WAS 292 MG/DL. THE USER ACKNOWLEDGED THE WARNING AND CONFIRMED THE BG AT 292 MG/DL. A SUBSEQUENT BG OF 315 MG/DL WAS ENTERED NEXT, UPON WHICH GLUCOMMANDER ALERTED THE USER THAT THE MAXIMUM INFUSION RATE HAD BEEN REACHED AND TO CONTACT THE PHYSICIAN. A FINAL BG OF 257 MG/DL WAS ENTERED 67 MINUTES LATER, 7 MINUTES PAST THE RECOMMENDED BG CHECK TIME. AFTER THIS FINAL BG WAS ENTERED, THE CUSTOMER STATED THE PATIENT HAD SEIZURES AND A SUBSEQUENT BG READING SHOWED SEVERE HYPOGLYCEMIA WHICH WAS NOT ENTERED INTO GLUCOMMANDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472448 GLUCOMMANDER PREDICTIVE PULMONARY FUNCTION VALUE CALCULATOR NDC GLYTEC, LLC 3.3.4.4 00860057000305

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death