BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLIS MICROPLATE SYSTEM

    MDR report key: 1527344 · Received October 23, 2009

    Report

    Report Number
    3022521-2009-00004
    Event Type
    Malfunction
    Date Received
    October 23, 2009
    Date of Event
    August 21, 2009
    Report Date
    October 20, 2009
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBSEQUENT RUN, ON EVOLIS (B)(4) ON (B)(4) 2009 (WHEN REACTIVE RESULTS WERE OBTAINED) SHOWED NO ERRORS AND THE SAMPLE IN QUESTION DEMONSTRATED THE SAME BARCODE ID AS REFLECTED IN PRIOR RUNS. ON (B)(4) 2009, A BIO-RAD LABORATORIES DIAGNOSTIC SERVICE SPECIALIST (DSS) WAS DISPATCHED TO THE SITE TO FURTHER INVESTIGATE THE EVOLIS INSTRUMENT USED IN THE (B)(4) 2009 TESTING. THE DSS INVESTIGATION INCLUDED PERFORMING A RUN OF TWO FULL PLATES OF POSITIVE CONTROLS. THE RESULTS WERE REACTIVE FOR ALL BUT THREE OF THE WELLS. THE EVENT LOG LISTED AN ERROR MESSAGE OF "NO LIQUID DETECTED" FOR THESE THREE WELLS. THIS ERROR PROMPTED THE DSS TO CHECK THE ALIGNMENT OF THE SAMPLE RACK. IN SPEAKING WITH THE OPERATORS AT THE CUSTOMER SITE, THE DSS DISCOVERED THAT THE OPERATORS WERE USING TUBES NOT DESIGNED FOR THEIR PRE-DEFINED SAMPLE RACK. CUSTOMERS ARE ROUTINELY TRAINED THAT ONCE A SAMPLE RACK IS CONFIGURED FOR A SPECIFIC SAMPLE TUBE TYPE, ONLY THAT TUBE TYPE IS TO BE USED. IF OTHER TUBE TYPES ARE TO BE USED, THE ASSOCIATED SAMPLE RACK MUST BE CONFIGURED TO ENSURE PROPER HANDLING BY THE EVOLIS. IN CONSIDERING ALL OF THE INFO OBTAINED DURING THIS INVESTIGATION, THERE ARE TWO POSSIBLE CAUSES FOR THE CUSTOMER OBTAINING NON-REACTIVE RESULTS ON THE (B)(4) 2009 TEST RUN. FIRST, IT IS POSSIBLE THAT THE CUSTOMER USED AN IMPROPERLY CONFIGURED SAMPLE RACK WHICH COULD HAVE RESULTED IN INCOMPLETE SAMPLE PIPETTING. SECOND, BASED ON THE APPEARANCE OF THE SAMPLE PROVIDED TO BIO-RAD PRODUCT SUPPORT, IT IS POSSIBLE THAT THE PRIMARY OR SECONDARY SAMPLE TUBE WAS MISLABELED OR THAT THE PRIMARY SAMPLE TUBE WAS INADVERTENTLY LOADED INTO A MISLABELED SECONDARY TUBE DURING THE (B)(4) 2009 TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2009, A CUSTOMER CONTACTED THE BIO-RAD LABORATORIES TECHNICAL SUPPORT DEPARTMENT REGARDING LOW OPTICAL DENSITY (OD) VALUES (0.009, 0.020) OBTAINED ON A SPECIFIC PT SAMPLE WHEN RUNNING THE GS RLAV (B)(4) EIA ASSAY ON THE EVOLIS MICROPLATE SYSTEM, S/N (B)(4). THE EVOLIS IS A 4-PLATE SELF-CONTAINED MICROPLATE PROCESSOR SYSTEM DESIGNED FOR USE WITH MULTIPLE EIA ASSAYS. THE CUSTOMER STATED THAT THE PT SAMPLE HAD BEEN SUBMITTED BY A LOCAL COUNTY DEPARTMENT OF HEALTH REQUESTING A RETEST OF A PT THAT HAD REPORTEDLY TESTED POSITIVE FOR (B)(6) ANTIBODIES IN THE PAST. THE CUSTOMER REPORTED THAT THE PT SAMPLE WAS TESTED IN DUPLICATE ON (B)(6) 2009, PRODUCING NON-REACTIVE RESULTS. THE PT SAMPLE WAS THEN RETESTED ON (B)(6) 2009, IN DUPLICATE, USING A DIFFERENT EVOLIS INSTRUMENT AND THE RESULT WAS REPEATEDLY REACTIVE. THE CUSTOMER REPORTED THAT THE PT SAMPLE WAS ALSO TESTED USING THE UNIGOLD RAPID (B)(6) AND (B)(6)-1 WESTERN BLOT, ON OR AFTER (B)(6) 2009, AND THAT THE RESULTS WERE POSITIVE ON THESE TESTS. BIO-RAD'S TECHNICAL SUPPORT DEPARTMENT REQUESTED A SAMPLE BE SENT TO BIO-RAD LABORATORIES FOR TESTING. THE PT SAMPLE WAS RECEIVED ON (B)(6) 2009 BY THE BIO-RAD PRODUCT SUPPORT DEPARTMENT, WHO OBSERVED THAT THE PRIMARY VIAL THE SAMPLE WAS IN WAS NOT THE ORIGINAL VIAL AND THAT IT WAS NOT LABELED WITH A BARCODE. INSTEAD THE INFO ON THE LABEL WAS HAND WRITTEN. PRODUCT SUPPORT TESTED THE PT SAMPLE ON THE GS RLAV (B)(4) EIA, LOT #044DAA, GS RLAV (B)(4) EIA, LOT #106DAA, THE BIO-RAD MULTISPOT (B)(4) RAPID TEST, LOT #961589 AND THE BIO-RAD GS (B)(4) WESTERN BLOT, LOT #962581. THE RESULT OF TESTING FOR BOTH RLAV (B)(4) EIA LOTS WAS REACTIVE, THE MULTISPOT TEST WAS (B)(4) REACTIVE, AND THE (B)(4) WESTERN BLOT TESTING WAS POSITIVE. RUN DATA AND EVENT LOGS WERE OBTAINED FROM THE EVOLIS S/N (B)(4). THE INITIAL TWO-PLATE RUN ON (B)(6) 2009 (WHEN THE NON-REACTIVE RESULTS WERE OBTAINED) SHOWED NO ERRORS ASSOCIATED WITH THE RUN. RUN DATA SHOWED THAT THE SAMPLE IN QUESTION HAD THE SAME BARCODE ID ON BOTH PLATES. TO FURTHER INVESTIGATE THE PERFORMANCE OF THE EVOLIS INSTRUMENT INVOLVED IN THE NON-REACTIVE RESULTS PRODUCED ON (B)(6) 2009, THE RESULT FILES OF RLAV PLATES RUN BETWEEN (B)(6) 2009 AND (B)(6) 2009 WERE REVIEWED. THESE PLATES WERE REVIEWED TO DETERMINE IF ANY OTHER LOW ODS, LIKE THOSE OBSERVED ON (B)(6) 2009, WERE PRESENT THROUGHOUT THIS PERIOD OF TIME. THERE WERE NO SAMPLES, OTHER THAN THE NON-REACTIVE RESULTS PRODUCED ON (B)(6) 2009, THAT DISPLAYED ON OD LOWER THAN 0.010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLIS MICROPLATE SYSTEM 4PS (FOUR PLATE SYSTEM) MZF BIO-RAD LABORATORIES, INC. EVOLIS

    Patients

    Seq Age Sex Outcome Treatment
    1