BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 3694609 · Received December 17, 2013

    Report

    Report Number
    1225673-2013-00002
    Event Type
    Malfunction
    Date Received
    December 17, 2013
    Report Date
    November 19, 2013
    Manufacturer
    DATA INNOVATIONS, INC.
    Product Code
    JQP
    PMA / PMN Number
    BK120051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT MANAGER IS ALSO LISTED AS MMH SOFTWARE, BLOOD BANK STAND ALONE PRODUCT. INSTRUMENT MANAGER IS CREATED USING INTERSYSTEMS CACHE, WHICH IS AN ADVANCED OBJECT DATABASE. ON (B)(6) 2013, DATA INNOVATIONS DETERMINED THAT THE CAUSE OF THE RULES NOT PROCESSING AFTER THE DIVIDE BY ZERO ISSUE OCCURRED WAS DUE TO A CACHE ERROR TRAPPING ISSUE. THIS ISSUE WAS CONFIRMED BY INTERSYSTEMS TO BE A PROBLEM WITH CACHE VERSIONS: 2011.1 THROUGH 2012.0, THESE VERSIONS WERE RELEASED FOR USE IN 2011. THIS WAS CORRECTED IN INTERSYSTEMS CACHE VERSION: 2012.1.0 IN 2012 WITH CHANGE CDS2047. ALL INSTRUMENT MANAGER 8.12 VERSIONS (V8.12.01, V8.12.02, V8.12.10, V8.12.11, V8.12.20, AND V8.12.21) WERE BUILT USING AFFECTED VERSIONS OF CACHE. THE FOLLOWING CACHE VERSIONS WERE USED TO CREATE THE FOLLOWING INSTRUMENT MANAGER (IM) VERSIONS: 2011.1.2.701.0.11458 - FOR IM V8.12.01, V8.12.02, V8.12.10, V8.12.11, V8.12.20, 2011.1.2.701.0.12368 - FOR IM V8.12.21. NOTIFICATION OF BUGS IN CACHE IS MADE VIA EMAIL ANNOUNCEMENTS FROM INTERSYSTEMS. INTERSYSTEMS DID NOT NOTIFY DATA INNOVATIONS OF THE BUG THAT CAUSED THIS ERROR TRAP NOR DID INTERSYSTEMS NOTIFY DATA INNOVATIONS WHEN THE ISSUE WAS CORRECTED. DATA INNOVATIONS SUBMITTED RECALL # 1225673-12/17/2013-002-C TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER SUPPORT INCIDENT # (B)(4) WAS SUBMITTED TO DATA INNOVATIONS (B)(4) ON (B)(6) 2013 BY ROCHE DIAGNOSTICS FOR (B)(6) FOR A RULES ISSUE THAT CAUSED THE RULES TO NOT PROCESS WHEN THE RULE HAD A DIVISION OF ZERO. THE LAB IS A HIGH VOLUME LAB AND WAS REVISING RULES TO FIT THEIR NEEDS WHEN THE LAB DETERMINED THAT RULES WERE NOT PROCESSED AFTER A DIVIDE BY ZERO ERROR OCCURS. ROCHE DIAGNOSTICS' TECHNICIAN CORRECTED THE PROBLEM FOR THE CUSTOMER BY REVISING THE RULE TO CHECK FOR A ZERO VALUE BEFORE DOING DIVISION. THERE WAS NO PT HARM REPORTED IN THIS INCIDENT BECAUSE THE LABORATORY CAUGHT AND CORRECTED THE RULE DURING TESTING OF THOSE RULES. IF A RULESET CONTAINS ENOUGH RULES TO CREATE A ROUTINE LARGER THAN 64KG IN SIZE AND AN ERROR OCCURS OR IF A RULE ATTEMPTS TO DIVIDE BY 0, SUBSEQUENT RULES MAY NOT BE EVAL. DURING THE SAVING OF RULES, THE RULES ARE CONVERTED FROM THEIR DISPLAY FORMAT INTO GENERATED ROUTINES THAT GET COMPILED AND EXECUTED AT RUNTIME. IF THE SIZE OF THE ROUTINE IS LARGER THAN 64KG, THIS ISSUE MAY OCCUR WHEN AN ERROR OCCURS. FOR THIS ISSUE TO OCCUR THE FOLLOWING CRITERIA MUST BE MET: THE GENERATED ROUTINE MUST BE GREATER THAN 64KB; IF THE PARENT OF THE CHILD RULE DOES NOT HAVE AN IF STATEMENT, THE ERROR MUST OCCUR IN THE SECOND CHILD OR SUBSEQUENT CHILD RULE. HOWEVER, IF THE PARENT OF THE CHILD RULE HAS AN IF STATEMENT, THE ERROR COULD OCCUR IN ANY CHILD RULE. THE RULE SET CRITERIA ARE MET, THE SUBSEQUENT SIBLING RULES IN THAT GROUP OF THE CHILD RULE THAT ERRED WILL NOT BE EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659530 INSTRUMENT MANAGER SOFTWARE JQP CALCULATOR/ DATA PROCESSING MODULE JQP DATA INNOVATIONS, INC. V8.12.01 -V8.12.21

    Patients

    Seq Age Sex Outcome Treatment
    1