BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDITECH BI-DIRECTIONAL INTERACTIVE COMMUNICATION ANALYZER INTERFACE

    MDR report key: 3478786 · Received May 13, 2013

    Report

    Report Number
    3009404844-2013-00001
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Report Date
    May 3, 2013
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY INC.
    Product Code
    OUG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: OTHER CODE UNSPECIFIED: SOFTWARE CONTRIBUTED TO PRODUCT PROBLEM. DEVICE AVAILABLE FOR EVALUATION: THE MAGIC AND CLIENT SERVICE BI-DIRECTIONAL INTERACTIVE COMMUNICATION ANALYZER INTERFACE SOFTWARE AT THE CUSTOMER LOCATION IS AVAILABLE TO MEDITECH STAFF THROUGH A SECURE VPN CONNECTION. THIS INTERFACE WORKS IN CONJUNCTION WITH THE MAGIC OR CLIENT SERVER MEDITECH LABORATORY SOFTWARE PRODUCT. THE CUSTOMER SITE HAS TWO SEPARATE LABORATORY DATABASES WITH THE SAME VERSION OF SOFTWARE: A TEST DATABASE USED FOR RESEARCH, TESTING, AND VERIFICATION; AND A LIVE DATABASE USED FOR RECORDING THE DAILY OPERATIONS OF THE HOSPITAL'S LABORATORY DEPARTMENT. MEDITECH MAINTAINS CONTROLLED TESTING ENVIRONMENTS FOR THE CUSTOMER VERSION AS WELL AS FOR ALL VERSIONS OF THE BI-DIRECTIONAL INTERACTIVE COMMUNICATION ANALYZER INTERFACE SOFTWARE. EVALUATION OF MALFUNCTION: AFTER INVESTIGATING THE ISSUE REPORTED BY THE CUSTOMER FOR MAGIC RELEASE 5.63, MEDITECH PERFORMED ADDITIONAL ON-SITE AND INHOUSE TESTING AND DETERMINED THAT THE SAME ISSUE AFFECTS MULTIPLE RELEASES OF MAGIC AND CLIENT SERVER. INVESTIGATION OF THE SOFTWARE IN MEDITECH'S CONTROLLED TESTING ENVIRONMENT FOUND THAT THIS ISSUE CAN OCCUR BECAUSE THE BI-DIRECTIONAL INTERACTIVE COMMUNICATION ANALYZER INTERFACE SAVES OFF THE UPLOADED INTERPRETATION FOR EACH LAB TEST. IF THE ANALYZER THEN UPLOADS A "NO RESULT" AND THERE ARE NO FLAGS FOR INTERPRETATIONS ON THE TRANSMISSION THEN THE SOFTWARE DOES NOT CLEAR THE PREVIOUS INTERPRETATION. THIS IS WHY THE RESULT WAS BEING SAVED AS "NEGATIVE" WHEN THERE SHOULD NOT HAVE BEEN ANY RESULTS. ALTHOUGH UNLIKELY, IF THE SITUATION WERE TO OCCUR IN A LIVE ENVIRONMENT, IT MAY BE POSSIBLE FOR A PATIENT TO RECEIVE UNNECESSARY TREATMENT POTENTIALLY LEADING TO A MEDICATION OVERDOSE BASED ON THE INCORRECTLY REPORTED RESULTS. THE ISSUE AFFECTS THE MAGIC BI-DIRECTIONAL INTERACTIVE COMMUNICATION ANALYZER INTERFACE RELEASES 5.41, 5.52, 5.53, 5.62, 5.63 AND 5.64 AND CLIENT SERVICE BI-DIRECTIONAL INTERACTIVE COMMUNICATION ANALYZER INTERFACE RELEASES 5.64, 5.65, 6.05, 6.06 AND 6.07. SOFTWARE CORRECTION: MEDITECH HAS MODIFIED THE SOFTWARE FOR ALL OF THE MAGIC AND CLIENT SERVER RELEASES NOTED ABOVE SO THAT THE INTERPRETIVE FLAGS FOR QUALITATIVE RESULTS WILL BE PROPERLY TRANSMITTED INTO THE MEDITECH LABORATORY SOFTWARE PRODUCT. WHEN A QUALITATIVE TEST WITHIN A TEST PANEL IS NOT PERFORMED ON A VITROS ANALYZER (MODELS 3600, 4600 AND 5600), THE PREVIOUS TEST'S RESULTS WILL NO LONGER BE ASSOCIATED TO THE TEST NOT PERFORMED. QUALITATIVE RESULTS FOR TEST PANELS CAN NOW BE RUN ON THE VITROS ANALYZERS (USED IN CONJUNCTION WITH THE MEDITECH BI-DIRECTIONAL INTERACTIVE COMMUNICATION ANALYZER INTERFACE) WITHOUT INCORRECT RESULTS BEING REPORTED FOR CERTAIN TESTS WHEN TESTS ARE NOT PERFORMED. CHANGES WERE MADE TO THE BI-DIRECTIONAL INTERFACE COMMUNICATION ANALYZER INTERFACE TO ENSURE THAT THE VARIABLE USED TO STORE THE INTERPRETIVE RESULT WILL BE CLEARED OUT IF AN INTERPRETATION IS NOT UPLOADED, PREVENTING THE INTERPRETATION FROM CARRYING OVER TO OTHER RESULTS. MEDITECH HAS EVALUATED THE DEVICE AFTER CORRECTIONS WERE MADE AND DETERMINED THE SOFTWARE IS WORKING AS INTENDED. THE FOLLOWING WORKAROUND HAS ALSO BEEN PROVIDED: THE TECHNOLOGISTS SHOULD REVIEW ANALYZER PRINTOUTS FROM THE VITROS 3600, 4600 AND 5600 FOR THE VALUE OF 'NO RESULT' AND CHECK FOR THE ACCURACY IN MEDITECH. NOTIFICATION AND DISTRIBUTION: BEGINNING ON MAY 7, 2013 MEDITECH DISTURBED A NOTIFICATION TO CUSTOMERS WHO HAVE THE MAGIC OR CLIENT SERVER BI-DIRECTIONAL INTERACTIVE COMMUNICATION ANALYZER INTERFACE IN EITHER TEST OR LIVE FOR THE RELEASES NOTED ABOVE. THIS NOTIFICATION WAS MADE VIA E-MAILED TASK UPDATES THAT CAN BE PRINTED BY THE CUSTOMER. TASK UPDATES SENT VIA E-MAIL ARE IMMEDIATELY TRANSMITTED TO THE CUSTOMER. CODE CHANGES ARE BEING PROVIDED TO ALL CUSTOMERS WHO COULD BE IMPACTED BEGINNING ON MAY 7, 2013.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A MEDITECH CUSTOMER REPORTED IN THEIR LIVE ENVIRONMENT THAT POSITIVE AND/OR TESTS NOT RESULTED THAT WERE TRANSMITTED INTO MEDITECH'S LABORATORY SOFTWARE FROM THE VITROS ANALYZER (MODEL 5600), WERE BEING REPORTED AS NEGATIVE. MEDITECH INVESTIGATED THE ISSUE AND THE ISSUE WAS REPRODUCED IN MEDITECH'S IN-HOUSE, CONTROLLED TESTING ENVIRONMENT ON (B)(6) 2013. THE VITROS ANALYZER BEING USED IN CONJUNCTION WITH A BI-DIRECTIONAL INTERACTIVE COMMUNICATION ANALYZER INTERFACE PERFORMS LABORATORY TESTS. THIS ISSUE ONLY OCCURS WITH QUALITATIVE (POSITIVE/NEGATIVE VS. NUMERIC RESULT) TEST PANELS. A COMMON QUALITATIVE REST PANEL RUN ON THIS ANALYZER IS A DRUG TOXICOLOGY TEST PANEL WHICH TYPICALLY INCLUDES MULTIPLE DRUGS. IN THIS SCENARIO, THE ANALYZER RAN OUT OF A REAGENT FOR ONE OF THE TESTS YIELDING A "NO RESULT" BEING REPORTED BY THE ANALYZER. THE ANALYZER INTERFACE WAS UNABLE TO INTERPRET THE "NO RESULT" VALUE. AS A RESULT, THE QUALITATIVE RESULT FROM THE PREVIOUS TEST ON THE PANEL WAS CARRIED OVER AND INCORRECTLY REPORTED ON THE UNRESULTED TEST. NO PATIENTS WERE HARMED DUE TO THIS ISSUE. IF THIS SITUATION WERE TO OCCUR IN A LIVE ENVIRONMENT, IT MAY BE POSSIBLE FOR A PATIENT TO RECEIVE UNNECESSARY TREATMENT POTENTIALLY LEADING TO A MEDICATION OVERDOSE, BASED ON THE INCORRECTLY REPORTED RESULTS. A WORKAROUND IS AVAILABLE: THE TECHNOLOGISTS SHOULD REVIEW ANALYZER PRINTOUTS FROM THE VITROS 3600, 4600 AND 5600 FOR THE VALUE OF 'NO RESULT' AND CHECK FOR THE ACCURACY IN MEDITECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212159 MEDITECH BI-DIRECTIONAL INTERACTIVE COMMUNICATION ANALYZER INTERFACE MEDITECH BI-DIRECTIONAL LAB ANALYZER INTERFACE OUG MEDICAL INFORMATION TECHNOLOGY INC. MAGIC 5.41. 5.52, 5.53, 5.62, 5.63, 5.64 AND CS 5.64, 5.65, 6.05, 6.06 AND 6.07

    Patients

    Seq Age Sex Outcome Treatment
    1