BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 1354423 · Received February 20, 2009

    Report

    Report Number
    1225673-2009-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    January 20, 2009
    Report Date
    February 18, 2009
    Manufacturer
    DATA INNOVATIONS, INC.
    Product Code
    JQP
    PMA / PMN Number
    BK080052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACTIONS TAKEN: SITE REPORTING THE PROBLEM HAS BEEN CONTACTED WITH INFORMATION ABOUT THE ISSUE, AND INFORMED OF THE TEMPORARY SOLUTION TO USE TO PREVENT THE PROBLEM. OTHER CUSTOMERS WHO MAY BE AFFECTED HAVE BEEN NOTIFIED OF THE ISSUE AND TEMPORARY SOLUTION. WORK ON THE PATCH OF SOFTWARE HAS BEGUN. ACTIONS TO BE TAKEN: A LETTER DESCRIBING THIS ISSUE AND RESOLUTION WILL BE SENT TO THE CUSTOMER BASE AFFECTED BY THIS ISSUE. THE SOFTWARE PATCH WILL BE MADE AVAILABLE FOR DOWNLOAD FROM OUR WEBSITE, AS PER OUR ESTABLISHED PROCEDURES. DATA INNOVATIONS WILL ASSIST ANY CUSTOMER WITH QUESTIONS OR NEEDING ASSISTANCE WITH APPLYING THE PATCH. EVAL SUMMARY: THE SITE REPORTING THIS ISSUE TO DATA INNOVATIONS DISCOVERED IT WHEN MANUALLY RE-RUNNING TESTS BUT NOT HAVING THOSE MANUALLY RE-RUN TESTS SUBSEQUENTLY BE HELD BY THE RULE THAT THEY WROTE IN THE INSTRUMENT MANAGER SOFTWARE. THE INSTRUMENT MANAGER SOFTWARE WAS NOT RETURNED TO US, BUT DATA INNOVATIONS EVALUATED DATA RETURNED TO US BY THE SITE REPORTING THE ISSUE. SPECIFICALLY, COMMUNICATIONS TRACE, SPECIMEN EVENT LOG, AUDIT TRAIL AND SPECIMEN TRACKING INFORMATION WAS GATHERED FROM THE SITE. REVIEW OF THIS INFORMATION ASSISTED IN THE INVESTIGATION OF THE PROBLEM AS REPORTED BY THE SITE. AFTER INVESTIGATION, IT WAS POSSIBLE TO REPRODUCE THE PROBLEM AT DATA INNOVATIONS AND THE CAUSE OF THE PROBLEM WAS IDENTIFIED. THE INVESTIGATION ALSO FOUND A METHOD OF OPERATION THAT WILL ENSURE THAT THIS ISSUE DOES NOT RECUR FOR SITES. THIS TEMPORARY WORK AROUND WAS COMMUNICATED TO CUSTOMERS UNTIL SUCH TIME AS A SOFTWARE PATCH CAN BE RELEASED.

    Description of Event or Problem · 1

    ISSUE: THE 'ANY TEST IS RERUN' DATA ELEMENT MAY NOT TRIGGER A RULE TO FIRE EVEN THOUGH A TEST IS MARKED AS A RERUN IN THE DATABASE. ISSUE DETAILS: THE 'ANY TEST IS RERUN' DATA ELEMENT MAY NOT PROPERLY EVALUATE A TEST AS BEING MARKED AS A RERUN IN THE SM DATABASE. THIS PROBLEM WILL MANIFEST ITSELF DEPENDING ON THE ORDER IN WHICH RESULTS ARE RECEIVED FROM THE INSTRUMENT AND THE ORDER IN WHICH THE TESTS WERE ADDED TO THE SM DATABASE. FOR THIS REASON, THE PROBLEM IS MORE LIKELY TO OCCUR THAN NOT.

    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