BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO TOOL SOFTWARE

    MDR report key: 2191085 · Received July 25, 2011

    Report

    Report Number
    3005214420-2011-00005
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    HOSPIRA POINT OF CARE SOLUTIONS
    Product Code
    NDC
    PMA / PMN Number
    K053137
    Removal / Correction Number
    NA
    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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE ENDOTOOL SOFTWARE PROGRAM RECOMMENDED LESS INSULIN DOSE THAN EXPECTED. THE ENDOTOOL GLUCOSE MANAGEMENT SYSTEM V7.2.1800.3 WAS BEING USED TO MANAGE THE PT'S BLOOD GLUCOSE (BG) LEVEL. IT WAS REPORTED THAT THE PT WAS PREVIOUSLY ON THE ENDOTOOL SOFTWARE ON (B)(6) 2011. IT WAS REPORTED THAT THE PT'S BR AND (DOSING CURVE VALUE) WAS 0.11. ON AN UNSPECIFIED DATE, THE PT WAS DISCONTINUED FROM THE ENDOTOOL SOFTWARE. ON (B)(6) 2011 AT AN UNSPECIFIED TIME, THE PT WAS RESTARTED ON THE ENDOTOOL SOFTWARE. THE NURSE ENTERED THE PT'S CURRENT INFO INTO THE ENDOTOOL SOFTWARE. AT AN UNSPECIFIED TIME, THE NURSE ENTERED AN INITIAL SERUM BG MEASUREMENT OF 1267MG/DL. THE ENDOTOOL SOFTWARE DISPLAYED A RECOMMENDATION OF 1 UNIT BOLUS DOSE OF REGULAR INSULIN, A REGULAR INSULIN DELIVERY AT A RATE OF 1.3 UNITS/HR OF REGULAR INSULIN, AND TO CHECK THE BG MEASUREMENT IN 30 MINUTES. THE NURSE DELIVERED THE RECOMMENDED DOSE. AT AN UNSPECIFIED TIME, THE NURSE RECHECKED THE PT'S BG AND OBTAINED A VALUE OF 600 MG/DL. THE VALUE WAS OBTAINED FROM A POINT OF CARE GLUCOMETER WHICH HAS A MAXIMUM VALUE OF 600 MG/DL. ENDOTOOL RECOMMENDED 1 UNIT BOLUS DOSE OF REGULAR INSULIN AND, A REGULAR INSULIN DELIVERY RATE OF 1.3 UNITS/HR AND TO CHECK THE BG MEASUREMENT IN 30 MINUTES. THE NURSE DID NOT DELIVER THE RECOMMENDED DOSE. THE NURSE CONTACTED ENDOTOOL SUPPORT. DURING TROUBLESHOOTING, IT WAS FOUND THAT THE ENDOTOOL SOFTWARE CALCULATED THE DOSING RECOMMENDATIONS BASED ON THE BR AND FROM (B)(6) 2011 INSTEAD OF CALCULATING A NEW BR AND BASED ON THE PT'S CURRENT INFO. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THE NURSE CREATED A NEW PT RECORD IN THE ENDOTOOL SOFTWARE USING THE CURRENT INFO. THE NURSE CHECKED THE PT'S BG WITH A POINT OF CARE GLUCOMETER AND OBTAINED THE VALUE OF 600 MG/DL. ENDOTOOL RECOMMENDED 11 UNITS BOLUS DOSE OF REGULAR INSULIN AND, A REGULAR INSULIN DELIVERY AT A RATE OF 13.5 UNITS/HR AND TO CHECK THE BG MEASUREMENT IN 30 MINUTES. THERE WERE NO REPORTED ADVERSE PT EFFECT AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO TOOL SOFTWARE 79NDC NDC HOSPIRA POINT OF CARE SOLUTIONS NA NAFN

    Patients

    Seq Age Sex Outcome Treatment
    1