BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 2913061 · Received January 7, 2013

    Report

    Report Number
    1225673-2013-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    September 30, 2012
    Report Date
    January 4, 2013
    Manufacturer
    DATA INNOVATIONS, INC.
    Product Code
    JQP
    PMA / PMN Number
    BK120051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS A BUG IN V8.00.0001 AND V8.00.0002 OF THE DRIVER. THIS BUG WAS IDENTIFIED, CORRECTED AND RELEASED BEFORE THIS CUSTOMER COMPLAINT OCCURRED. WHEN THE ORIGINAL BUG WAS REPORTED, NO PATIENT SAFETY CONCERNS WERE RAISED AT THAT TIME. THE PATIENT SAFETY ISSUE WAS NOT BROUGHT TO DATA INNOVATION¿S ATTENTION UNTIL AFTER THE PATCH WAS RELEASED. THIS RESULTED IN A DELAY IN REPORTING THE ISSUE TO THE FDA IN A TIMELY MANNER. A CAPA INCIDENT IS BEING OPENED TO DETERMINE WHY THE PATIENT SAFETY ISSUE WAS NOT IDENTIFIED SOONER. ACTIONS TAKEN: SITE REPORTING THE PROBLEM HAS BEEN CONTACTED WITH INFORMATION ABOUT THE ISSUE, AND INFORMED OF THE SOLUTION TO USE TO PREVENT THE PROBLEM. THE DRIVER HAS BEEN CORRECTED AND WAS RELEASED SEPTEMBER 14, 2012. THE SOFTWARE PATCH IS AVAILABLE FOR DOWNLOAD FROM OUR WEBSITE, AS PER OUR ESTABLISHED PROCEDURES. AN EMAIL DESCRIBING THIS ISSUE AND RESOLUTION WAS SENT TO THE CUSTOMER BASE AFFECTED BY THIS ISSUE ON (B)(4) 2012. DATA INNOVATIONS WILL ASSIST ANY CUSTOMER WITH QUESTIONS OR NEEDING ASSISTANCE WITH APPLYING THE PATCH. CAPA INCIDENT OPENED TO RESEARCH WHY PATIENT SAFETY WAS NOT IDENTIFIED EARLIER IN THE COMPLAINT HANDLING PROCESS.

    Description of Event or Problem · 1

    ISSUE: WHEN USING THE ROCHE COBAS E411 (RCHCE4LI) DRIVER VERSION 8.00.0001 OR 8.00.0002, WITH INSTRUMENT MANAGER, IF THERE IS A BARCODE READ ERROR, THE CURRENT SAMPLE MAY BE IDENTIFIED AS THE LAST SAMPLE ID THAT WAS IN THAT RACK/DISK POSITION, POTENTIALLY CAUSING SAMPLE MISMATCH. IF THE LAST SAMPLE HAD ANY PENDING TESTS IN THE ORDERS DATABASE, TEST SELECTION WOULD BE DOWNLOADED TO THE INSTRUMENT WITH THE INCORRECT SAMPLE ID, AND RESULTS WOULD REPORT ON THE WRONG SAMPLE. ISSUE DETAILS: LIS DOWNLOADED A TEST ORDER (TEST ID (B)(6)) IN DUPLICATE FOR SAMPLE 1. SAMPLE 1 WAS LOADED TO POSITION 3 OF A RACK/DISK 123, THE INSTRUMENT QUERIED IM AND RECEIVED AN ORDER FOR TEST ID (B)(6). THE INSTRUMENT RAN THE TEST AND CORRECTLY GENERATED AND REPORTED A RESULT. LATER, SAMPLE 2 IS PLACED IN POSITION 3 OF THE RACK/DISK 123, BUT WHEN THE INSTRUMENT TRIED TO READ IT, THERE WAS A BARCODE READ ERROR AND IM DOWNLOADED THE PENDING TEST FOR SAMPLE 1. THIS BARCODE ERROR CAUSED IM TO INCORRECTLY IDENTIFY THE SAMPLE BASED ON THE RACK/DISK AND POSITION WHICH SUBSEQUENTLY CAUSED THE INSTRUMENT TO RUN TESTS ON THE SAMPLE INCORRECTLY AND RESULTS REPORTED WITH THE WRONG SPECIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8147 INSTRUMENT MANAGER SOFTWARE JQP CALCULATOR/DATA PROCESSING MODULE JQP DATA INNOVATIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1