BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTLAB

    MDR report key: 775936 · Received August 21, 2006

    Report

    Report Number
    1058332-2006-00020
    Event Type
    Malfunction
    Date Received
    August 21, 2006
    Report Date
    July 18, 2006
    Manufacturer
    SCC SOFT COMPUTER
    Product Code
    LNX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN ALTERNATIVE SOLUTION, WHICH MAY HELP ALLEVIATE PART OF THIS PROBLEM, CONCERNS THE HOSPARAMS, "HISRR_RBS_SYNC" AND "AUTO_ SYNC_RBS". IF ONE OR BOTH HOSPARAMS ARE SET TO "N" THEN ONE HOSPARAM CAN LOCK THE OTHER ONE. IF THE RBS IS LOCKED, THE RULE WILL NOT RUN. IF BOTH HOSPARAMS ARE SET TO "Y" THEN HIS RESULT REPORTING AND RBS WILL BE SYNCHRONIZED, AND WILL NOT CAUSE A LOCK. THIS ALTERNATIVE SOLUTION CORRECTED THE PROBLEM FOR THE CLIENT. THEY HAVE NOT SEEN ANY ADDITONAL PROBLEMS. RESOLUTION: CORRECTION RECOMMENDATION FOR THE REPORTING CLIENT: PATCH FOR 4.0.1.X. NOTIFICATION RECOMMENDATION FOR THE REMAINING AFFECTED CLIENT BASE: NOTIFY ALL AFFECTED CLIENTS. CORRECTION RECOMMENDATIONS FOR THE REMAINING AFFECTED CLIENT BASE: PROVIDED THE CORRECTION IN AN UPGRADE OR COMPREHENSIVE PATCH, AND TO ADVISE CLIENTS TO SET THE HOSPARAMS HISRR_RBS_SYNC AND AUTO_SYNC_ RBS TO "Y".

    Description of Event or Problem · 1

    THE CLIENT REPORTED THAT A "C" TYPE RBS RULE, WHICH SHOULD SEND QUALIFYING RESULTS TO THE CALL LIST DID NOT SEND A RESULT TO THE CALL LIST FOR A RESULT THE USER DEFINED IN RBS SETUP AS A LIFE THREATENING RESULT, UGLU1, URINE GLUCOSE. THERE IS ANOTHER ISSUE THAT CAN PREVENT THE "C" RULE FROM BEING TRIGGERED. THE HOSPARAMS "HISRR_RBS_SYNC" AND "AUTO_SYNC_RBS" CAN CAUSE THE LOCKING OF THIS ORDER, PREVENTING THE RBS "C" RULE FROM TRIGGERING. TO CORRECT THIS ISSUE BOTH HOSPARAMS SHOULD BE SET TO "Y" THEN BOTH HOSPARAMS WILL WORK TOGETHER WITHOUT CAUSING ANY LOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTLAB SOFTLAB LNX SCC SOFT COMPUTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *