BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO TOOL SOFTWARE

    MDR report key: 2030552 · Received March 18, 2011

    Report

    Report Number
    3005214420-2011-00003
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 18, 2011
    Manufacturer
    HOSPIRA POINT OF CARE SOLUTIONS
    Product Code
    NDC
    PMA / PMN Number
    K053137
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED INACCURATE DOSING RESULTING IN AN ADVERSE EVENT WHILE THE DEVICE WAS IN USE. THE ENDOTOOL GLUCOSE MANAGEMENT SYSTEM, (B)(4), WAS BEING USED TO MANAGE THE PT'S BLOOD GLUCOSE (BG) LEVEL. ON (B)(6) 2011 AT AN UNSPECIFIED TIME, THE NURSE ENTERED THE PT'S INFO INTO THE ENDOTOOL SOFTWARE. AT 1317, THE NURSE ENTERED AN INITIAL SERUM BG MEASUREMENT OF 1041 MG/DL. BETWEEN 1355 AND 1644, THE PT'S BG MEASUREMENT WAS 600 MG/DL. THESE VALUES WERE OBTAINED FROM A POINT OF CARE GLUCOMETER, WHICH HAS A MAXIMUM VALUE OF 600 MG/DL. THE ACTUAL BG MEASUREMENTS WERE UNK. DURING THIS TIME PERIOD, ENDOTOOL RECOMMENDED BETWEEN 11.4 UNITS/HR TO 37.1 UNITS/HR AND BETWEEN 12 UNITS TO 31 UNIT BOLUS DOSES OF REGULAR INSULIN BE ADMINISTERED AND TO CHECK THE BG MEASUREMENT IN 30 MINUTES. THE NURSE DELIVERED THE RECOMMENDED DOSES. BETWEEN 1716 & 0426 ON (B)(6) 2011, THE PT'S BG MEASUREMENTS RANGED FROM 486 MG/DL TO 99 MG/DL. DURING THIS TIME, ENDOTOOL RECOMMENDED BETWEEN 1.8 UNITS/HR AND 31.3 UNITS/HR OF REGULAR INSULIN TO BE ADMINISTERED. THE NURSE DELIVERED THE RECOMMENDED DOSES. AT 0633, THE PT'S BG MEASUREMENT WAS 91 MG/DL. ENDOTOOL RECOMMENDED 1.3 UNITS/HR OF REGULAR INSULIN TO BE ADMINISTERED AND TO RECHECK THE BG MEASUREMENT 2 HOURS LATER. THE NURSE DELIVERED THE RECOMMENDED DOSE. AT 0759, THE PT'S BG MEASUREMENT WAS 54 MG/DL. ENDOTOOL RECOMMENDED 40 ML OF 50% DEXTROSE IN WATER TO BE GIVEN AND TO RECHECK THE BG MEASUREMENT 30 MINUTES LATER. THE NURSE ADMINISTERED THE RECOMMENDED DOSE AND RECHECKED THE BG MEASUREMENT 40 MINUTES LATER. AT 0839, THE PT'S BG MEASUREMENT WAS 79 MG/DL. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO TOOL SOFTWARE NDC HOSPIRA POINT OF CARE SOLUTIONS NA NAFN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention REGULAR INSULIN, MFR UNK