BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO TOOL SOFTWARE

    MDR report key: 1760936 · Received July 14, 2010

    Report

    Report Number
    3005214420-2010-00011
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 14, 2010
    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

    THE DEVICE WAS EVALUATED. TESTING AND INVESTIGATION FOUND THAT WHEN THE USER FACILITY'S AUTOMATED DATA TRANSFER (ADT) IS USED FOR DATA TRANSFER INTO THE ENDOTOOL V7.2.1800.0, A PRESET OF ZERO IS SET BY THE SOFTWARE FOR THE BASAL RATE (BR) AND F VALUE. IT WAS DETERMINED THAT AFTER A SPECIFIC SET OF KEY STROKES WERE ENTERED INTO THE SOFTWARE BY THE USER, THE ALGORITHM WITHIN THE SOFTWARE LOOKED FOR THE LOWEST BR VALUE AND F VALUES TO BE UTILIZED IN THE INSULIN DOSE CALCULATION WHICH WAS SET TO ZERO. THE SOFTWARE CONTINUED TO UTILIZE THE ZERO BR AND F VALUES, AND RECOMMENDED AN INSULIN DRIP RATE OF ZERO. THIS HAS BEEN CORRECTED IN A LATER VERSION OF THE SOFTWARE V7.2.1800.3. ADDITIONALLY, IT WAS FOUND THAT THE INITIAL MOBILE WORKSTATION COMPUTER WAS RUNNING DOWN REVISION OF THE ENDOTOOL SOFTWARE, V7.2.1800.0 THE SECOND MOBILE WORKSTATION WAS RUNNING THE CURRENT SOFTWARE VERSION, V7.2.1800.3. IT WAS FOUND THE USER FACILITY HAD INADVERTENTLY REIMAGED THE INITIAL MOBILE WORKSTATION LOADING DOWN REVISION SOFTWARE AND RELEASED IT TO THE CLINICAL SETTING. THE DATA THAT WAS ENTERED USING THE INITIAL MOBILE WORKSTATION WITH THE DOWN REVISION SOFTWARE AFFECTED ALL SUBSEQUENT CALCULATIONS FOR THIS PATIENT. THE MOBILE WORKSTATION COMPUTER WITH V7.2.1800.0 WAS REMOVED FROM CLINICAL USE AND UPGRADED TO V.7.2.1800.3. THIS DEVICE WAS IDENTIFIED AS PART OF A CUSTOMER NOTIFICATION DATED DECEMBER 05, 2008. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE ENDOTOOL SOFTWARE PROGRAM DID NOT PROVIDE AN INSULIN DOSE RECOMMENDATION WHEN A BLOOD GLUCOSE MEASUREMENT WAS ENTERED INTO THE SOFTWARE ON A MOBILE WORKSTATION COMPUTER DUE TO THE USER FACILITY WAS USING DOWN REVISION SOFTWARE. THE ENDOTOOL GLUCOSE MANAGEMENT SYSTEM V7.2.1800.0 WAS BEING USED TO MANAGE THE PATIENT'S BLOOD GLUCOSE LEVEL. NO SPECIFIC PARAMETERS WERE PROVIDED. THE NURSE STARTED THE PATIENT ON THE ENDOTOOL SOFTWARE AND ENTERED AN INITIAL BLOOD GLUCOSE MEASUREMENT OF 389 MG/DL. THE ENDOTOOL SOFTWARE DISPLAYED A RECOMMENDATION OF "0 INFUSION AT THIS TIME. RECHECK IN 1 HOUR." THE NURSE RECHECKED THE PATIENT'S BLOOD GLUCOSE AN HOUR LATER AND OBTAINED A BLOOD GLUCOSE MEASUREMENT OF 345 MG/DL. THE VALUE WAS ENTERED INTO THE ENDOTOOL SOFTWARE AND THE SOFTWARE DISPLAYED THE RECOMMENDATION, "0 INFUSION AT THIS TIME. RECHECK IN 1 HOUR." THE NURSE WENT TO A SECOND MOBILE WORKSTATION COMPUTER WITH V7.2.1800.3 INSTALLED AND ENTERED THE CURRENT BLOOD GLUCOSE MEASUREMENT. THE NURSE RECEIVED THE SAME RECOMMENDATION. THE USER FACILITY PRINTED THE PATIENT'S ENDOTOOL RECORD AND DELETED THE BLOOD GLUCOSE MEASUREMENTS. THE NURSE RECHECKED THE PATIENT'S BLOOD GLUCOSE LEVEL AND RESTARTED THE MANAGEMENT OF THE PATIENT'S BLOOD GLUCOSE LEVEL USING A MOBILE WORKSTATION COMPUTER WITH V7.2.1800.3 INSTALLED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK