BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 912737 · Received September 13, 2007

    Report

    Report Number
    1225673-2007-00001
    Event Type
    Malfunction
    Date Received
    September 13, 2007
    Date of Event
    August 22, 2007
    Report Date
    September 6, 2007
    Manufacturer
    DATA INNOVATIONS, INC.
    Product Code
    JQP
    PMA / PMN Number
    BK060053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCOPE OF THIS ISSUE IS LIMITED TO INSTRUMENT MANAGER VERSIONS. ALSO, ONLY CUSTOMERS USING THE SPECIMEN MANAGEMENT FEATURE COULD POTENTIALLY BE AFFECTED. RESEARCH OF OUR PAST CUSTOMER COMPLAINTS AND OUR FIELD HISTORY SHOWS THAT DATABASE ISSUES OCCUR VERY INFREQUENTLY. AND, DETAILED CODE-REVIEW SHOWS THAT THE ONLY REASONABLE CAUSE FOR THE IDENTIFIED APPLICATION INTEGRITY PROBLEMS ARE DUE TO A SYSTEMS DATABASE FILE FILLING AT THE PRECISE INSTANT A RESULT WAS BEING FILED IN THE DATABASE. THIS WOULD CAUSE AN INCOMPLETE RECORD OF THE DATA. HOWEVER, BECAUSE DI IS UNABLE TO DETERMINE A ROOT CAUSE OF THE ISSUE AT THIS TIME, ACTIONS WILL BE TAKEN TO ASSIST POTENTIALLY AFFECTED CUSTOMERS. ACTIONS TO BE TAKEN: DATA INNOVATIONS WILL NOTIFY ALL POTENTIALLY AFFECTED CUSTOMERS, ALERTING THEM THAT THERE MAY BE APPLICATION INTEGRITY ISSUES WITH CERTAIN VERSIONS OF SOFTWARE. DI WILL DISTRIBUTE A UTILITY THAT WILL CHECK THE INTEGRITY OF THE DATA, CORRECT ANY CORRUPTIONS, AND PROVIDE USERS WITH A REPORT. DI WILL ALSO UPDATE RELEVANT PRODUCT DOCUMENTATION TO ENSURE CUSTOMERS KNOW THE RECOMMENDED PROCEDURES FOR CHECKING APPLICATION INTEGRITY WHEN CACHE STOPS DUE TO AN ABNORMAL EVENT, SUCH AS A DATABASE/DRIVE FILLING OR A POWER OUTAGE. NOTE: THE SUPPLIED TOOL WOULD ONLY BE FOR THE SOFTWARE VERSIONS IDENTIFIED. THIS IS NOT NECESSARY FOR V8.05 AND LATER. EVALUATION SUMMARY: THE SITE REPORTING THIS ISSUE TO DATA INNOVATIONS DISCOVERED IT AS LAB STAFF CHECKED RESULTS IN THEIR LABORATORY INFORMATION SYSTEM, AND SO NO HARM WAS CAUSED TO ANY PATIENT OR USER RELATED TO THE MIS-REPORTED DATA THAT WAS REPORTED BY THE SITE. ADDITIONAL INVESTIGATION WILL EVALUATED OTHER AFFECTED SPECIMENS TO VERIFY THAT NO HARM WAS CAUSED TO ANY PATIENT OR USER AS A RESULT OF ADDITIONAL MIS-ASSOCIATION OF DATA THAT IS UNK TO US AT THIS TIME. THE INSTRUMENT MANAGER SOFTWARE WAS NOT RETURNED TO DATA INNOVATIONS, BUT DI STAFF HAS EVALUATED DATA RETURNED TO US BY THE SITE REPORTING THE ISSUE. SPECIFICALLY, AUDIT TRAIL AND SPECIMEN EVENT LOG INFORMATION WAS GATHERED AND REVIEWED. REVIEW OF THIS INFORMATION ASSISTED IN THE INVESTIGATION OF THE PROBLEM AS REPORTED BY THE SITE. AFTER DETAILED CODE-REVIEW, THE ONLY REASONABLE CAUSES FOR THE IDENTIFIED APPLICATION INTEGRITY PROBLEMS ARE DUE TO CACHE STOPPING DUE TO AN ABNORMAL EVENT, SUCH AS A SYSTEMS DATABASE/DRIVE FILING OR A POWER OUTAGE AT THE PRECISE INSTANT A SPECIMEN IS FILED IN THE DATABASE. THESE CONDITIONS COULD CAUSE AN INCOMPLETE RECORD OF THE DATA. HOWEVER, AT THIS POINT IN THE INVESTIGATION, IT IS NOT POSSIBLE TO REPRODUCE THE PROBLEM AT DATA INNOVATIONS. FOR THIS REASON A CONCLUSIVE ROOT CAUSE OF THE DATABASE CORRUPTION HAS YET TO BE DETERMINED. DI STAFF WAS ABLE TO CORRECT THE CORRUPTED DATABASE AND CONTINUES TO EVALUATE THE REPORTING SITE'S DATA ON A WEEKLY BASIS TO VERIFY THAT THIS CORRECTION IS EFFECTIVE.

    Description of Event or Problem · 1

    ISSUE SUMMARY: CORRUPT INDICES IN THE SPECIMEN MANAGEMENT DATABASE CAUSED THE MISASSOCIATION OF TEST AND TEST RESULT. SPECIFICALLY: A RESULT FOR THE "FBS" TEST WAS REPORTED AS THE RESULT FOR THE "H" TEST. DETAILS: INVESTIGATION IS STILL ONGOING AT THIS TIME. THE REPORTING SITE FOUND THIS PROBLEM WITH ONE SPECIMEN, BUT FURTHER INVESTIGATION SHOWED THE CORRUPTED INDICES AFFECTED 29 SPECIMENS. THE MIS-REPORTED DATA HIGHLIGHTED BY THE SITE DID NOT AFFECT PATIENT CARE IN ANY WAY. FURTHER INVESTIGATION WILL DETERMINE IF ANY OF THE OTHER AFFECTED SPECIMENS WERE MIS-REPORTED AND NEGATIVELY IMPACTED PATIENT CARE. AT THIS TIME, DI IS UNABLE TO CONCLUSIVELY DETERMINE WHAT CAUSED THE INDICES TO BECOME CORRUPTED. (SEE EVALUATION SUMMARY). DI HAS MONITORED THE REPORTING SITE'S SYSTEM FOR TWO WEEKS WITHOUT ANY FURTHER ISSUES. DI STAFF WILL CONTINUE TO MONITOR THE REPORTING SITE'S DATA ON A WEEKLY BASIS UNTIL FURTHER NOTICE TO VERIFY THAT THE CORRUPTION WAS ISOLATED AND DOES NOT RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTRUMENT MANAGER SOFTWARE JQP CALCULATOR/DATA PROCESSING MODULE JQP DATA INNOVATIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR