BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 8144342 · Received December 7, 2018

    Report

    Report Number
    1225673-2018-00014
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    November 8, 2018
    Report Date
    December 7, 2018
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS WAS AN INTERNALLY FOUND MALFUNCTION. NO KNOWN INSTANCES OF THIS MALFUNCTION OCCURRING IN THE FIELD ARE KNOWN. THE INVESTIGATION INTO THIS MALFUNCTION IS CONTINUING AND A CONCLUSION HAS NOT YET BEEN REACHED AS TO WHETHER IF THIS MALFUNCTION WERE TO REOCCUR THERE IS POTENTIAL FOR DEATH OR SERIOUS INJURY OF PATIENT. WHILE THE INVESTIGATION IS UNDERWAY DATA INNOVATIONS IS REPORTING THIS AS A MALFUNCTION IN AN ABUNDANCE OF CAUTION SHOULD DATA INNOVATIONS LATER DETERMINE THIS MALFUNCTION, IF IT WERE TO OCCUR IN THE FIELD, WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. UPDATED 04JAN2019: THE INVESTIGATION OF THIS ISSUE RESULTED IN IDENTIFICATION OF A DEFECT IN THE SOFTWARE CODE. THE ISSUE WAS REVIEWED BY TWO LABORATORY SUBJECT MATTER EXPERTS (LAB SMES), AND IT WAS DETERMINED THAT ONLY TWO OF THE AFFECTED FIELDS COULD HAVE CLINICALLY SIGNIFICANT USE: REFERENCE RANGE AND RESISTANCE MARKERS. IN DISCUSSIONS WITH THE LAB SME'S, IT WAS CONCLUDED THAT THERE IS NO CLINICALLY VALID USE OF A REFERENCE RANGE OF 26 CHARACTERS IN LENGTH, THEREFORE THE CHANCE OF HARM IS REMOTE. FOR THE RESISTANCE MARKERS, A MICROBIOLOGY RESULT WOULD ALWAYS HAVE A SUSCEPTIBILITY RESULT, AND RESISTANCE MARKERS WOULD NOT BE THE ONLY INFORMATION USED TO MAKE A CLINICAL DECISION, THEREFORE THE CHANCE OF HARM IS REMOTE. INVESTIGATION BY THE DIRECTOR OF DEVELOPMENT DETERMINED THAT OVERALL THERE ARE THREE DRIVERS IN THE DATA INNOVATIONS DRIVER LIBRARY THAT WOULD SUPPORT THE RESISTANCE MARKERS FIELD: BAYRPCMI - BAYER RAPIDCOMM - RESISTANCE MARKERS CAN BE PARSED AS THIS IS A CONFIGURABLE FIELD. HOWEVER, INSTRUMENT DOES NOT SPECIFICALLY SEND RESISTANCE MARKERS. BDCECTRI - BD EPICENTER - NOT POSSIBLE TO HIT 26 CHARACTERS EXACTLY. HLCPLT3I - HELENA PLATINUM 3 - RESISTANCE MARKERS CAN BE PARSED AS THIS IS A CONFIGURABLE FIELD. HOWEVER, INSTRUMENT DOES NOT SPECIFICALLY SEND RESISTANCE MARKERS. THE FINAL CONCLUSION IS THERE IS A CODE DEFECT IN INSTRUMENT MANAGER, THE MALFUNCTION HAS A REMOTE OR LESS CHANCE OF CAUSING DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 0

    DATA INNOVATIONS IDENTIFIED A SOFTWARE MALFUNCTION IN INTERNAL TESTING WHERE THE INSTRUMENT MANAGER SOFTWARE PRODUCT, IN VERY SPECIFIC SCENARIOS WITH A SPECIFIC LENGTH DATA ELEMENT IN CERTAIN DATA FIELDS (26 CHARACTERS), SPECIMEN AND TEST DATA MAY NOT BE CORRECTLY PASSED TO THE LABORATORY INFORMATION SYSTEM (LIS). AS A RESULT THE LIS SYSTEM MAY NOT TAKE APPROPRIATE ACTIONS ON THE DATA WHEN SUCH ACTIONS RELY ON VALUES IN THESE FIELD SUCH AS FLAGGING A RESULT AS "HIGH" OR "LOW" BASED ON A REFERENCE RANGE VALUE.

    Additional Manufacturer Narrative · 1

    THIS WAS AN INTERNALLY FOUND MALFUNCTION. NO KNOWN INSTANCES OF THIS MALFUNCTION OCCURRING IN THE FIELD ARE KNOWN. THE INVESTIGATION INTO THIS MALFUNCTION IS CONTINUING AND A CONCLUSION HAS NOT YET BEEN REACHED AS TO WHETHER IF THIS MALFUNCTION WERE TO REOCCUR THERE IS POTENTIAL FOR DEATH OR SERIOUS INJURY OF PATIENT. WHILE THE INVESTIGATION IS UNDERWAY DATA INNOVATIONS IS REPORTING THIS AS A MALFUNCTION IN AN ABUNDANCE OF CAUTION SHOULD DATA INNOVATIONS LATER DETERMINE THIS MALFUNCTION, IF IT WERE TO OCCUR IN THE FIELD, WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    DATA INNOVATIONS IDENTIFIED A SOFTWARE MALFUNCTION IN INTERNAL TESTING WHERE THE INSTRUMENT MANAGER SOFTWARE PRODUCT, IN VERY SPECIFIC SCENARIOS WITH A SPECIFIC LENGTH DATA ELEMENT IN CERTAIN DATA FIELDS (26 CHARACTERS), SPECIMEN AND TEST DATA MAY NOT BE CORRECTLY PASSED TO THE LABORATORY INFORMATION SYSTEM (LIS). AS A RESULT THE LIS SYSTEM MAY NOT TAKE APPROPRIATE ACTIONS ON THE DATA WHEN SUCH ACTIONS RELY ON VALUES IN THESE FIELD SUCH AS FLAGGING A RESULT AS "HIGH" OR "LOW" BASED ON A REFERENCE RANGE VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983100 INSTRUMENT MANAGER SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP DATA INNOVATIONS LLC V8.05

    Patients

    Seq Age Sex Outcome Treatment
    1