BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDITECH LABORATORY

    MDR report key: 7352962 · Received March 20, 2018

    Report

    Report Number
    3009404844-2018-00001
    Event Type
    Injury
    Date Received
    March 20, 2018
    Report Date
    March 6, 2018
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY, INC.
    Product Code
    MMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS NOT DUE TO A SOFTWARE MALFUNCTION WITHIN THE CLASS I MEDITECH LAB PRODUCT. IT WAS DUE TO A CUSTOMER-DEFINED CALCULATION THAT THE CUSTOMER HAD WRITTEN IMPROPERLY. TO MINIMIZE THE RISK OF POTENTIAL PATIENT HARM, MEDITECH EXPECTS CUSTOMERS TO VALIDATE CUSTOMER-DEFINED CALCULATIONS IN THEIR TEST ENVIRONMENT PRIOR TO USE IN A LIVE ENVIRONMENT. PER THE COLLEGE OF AMERICAN PATHOLOGISTS (CAP), GEN.43450, LABORATORIES ARE REQUIRED TO VALIDATE CALCULATIONS INVOLVING REPORTABLE PATIENT RESULTS. THE CALCULATIONS MUST BE RECHECKED EVERY TWO YEARS (OR WHEN A SYSTEM CHANGE IS MADE) TO ENSURE ACCURACY AND RECORDS OF THE VALIDATION ARE RETAINED. THE VALIDATION SHOULD INCLUDE LABORATORY INFORMATIONS SYSTEMS, MIDDLEWARE AND ANALYZERS. THE RECOMMENDED WORKAROUND TO PREVENT THIS ISSUE FROM RECURRING IS TO INACTIVATE THE CALCULATION UNTIL IT CAN BE REVIEWED, CORRECTED, AND VALIDATED IN TEST BEFORE USE IN A LIVE ENVIRONMENT. IN THIS INSTANCE, MEDITECH REVIEWED THE CALCULATION WITH THE CUSTOMER ON (B)(6) 2018 AND ASSISTED THEM IN CORRECTING THE CALCULATION SO THE RESULTS WOULD BE PROPERLY FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2018 A CUSTOMER REPORTED AN INCORRECT RESULT FILED TO THE CREATINE KINASE (CK) TEST IN THEIR MEDITECH LABORATORY LIVE ENVIRONMENT. MEDITECH INVESTIGATED THE REPORTED ISSUE AND DETERMINED THE RESULT OF "<5" WAS FILED DUE TO A USER-DEFINED ERROR THROUGH A CUSTOMER DEFINED CALCULATION. AS THE RESULT WAS REPORTED BY THE CUSTOMER-DEFINED CALCULATION AS NORMAL, NO INTERVENTION WAS TAKEN, WHICH LED TO THE PATIENT ULTIMATELY BEING FOUND UNCONSCIOUS. THE PATIENT'S INITIAL CK LEVEL WAS "2700" AND WHEN THE PATIENT WAS FOUND UNCONSCIOUS IT WAS "7000".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199099 MEDITECH LABORATORY MEDITECH LABORATORY SOFTWARE MMH MEDICAL INFORMATION TECHNOLOGY, INC. CLIENT SERVER RELEASE 5.67

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention