BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLIS MICROPLATE SYSTEM

    MDR report key: 1236853 · Received November 3, 2008

    Report

    Report Number
    3022521-2008-00006
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 6, 2008
    Report Date
    November 3, 2008
    Manufacturer
    STRATEC BIOMEDICAL SYSTEMS AG
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CO IS CURRENTLY WORKING WITH THE MANUFACTURER OF THE EVOLIS INSTRUMENT TO FURTHER INVESTIGATE AND CORRECT THIS ISSUE.

    Description of Event or Problem · 1

    CO RECEIVED A PHONE CALL FROM DEPARTMENT OF HEALTH. THE CUSTOMER CALLED THE REPORT OBTAINING INVALID EXTERNAL QUALITY CONTROL RESULTS WHEN RUNNING THE GS RLAV HIV-1 EIA ASSAY ON THE EVOLIS MICROPLATE SYSTEM MANUFACTURED BY ANOTHER COUNTRY'S MFR. THE EVOLIS IS A 4-PLATE SELF-CONTAINED MICROPLATE PROCESSOR SYSTEM DESIGNED FOR USE WITH MULTIPLE EIA ASSAYS. BIO-RAD LABORATORIES TECHNICAL SUPPORT DEPARTMENT REQUESTED THAT THE CUSTOMER FAX THEIR DATA FOR REVIEW. DURING THE DATA REVIEW, THE BIO-RAD TECHNICAL SERVICE REPRESENTATIVE (TSR) OBSERVED A PATIENT SAMPLE FROM A RUN IN 2008, WITH AN OPTICAL DENSITY (OD) VALUE OF 0.220, WHICH IS SLIGHTLY BELOW THE ASSAY CUT-OFF. THIS 0.220 RESULT WAS OBTAINED ON A MICROWELL PLATE THAT ALSO EXHIBITED A NUMBER OF VERY LOW OD VALUES (0.010). THE PRESENCE OF THE <0.010 ODS SUGGESTED TO THE BIO-RAD TSR THE POSSIBILITY THE 0.220 VALUE MIGHT BE A POSITIVE SAMPLE THAT WAS SOMEHOW TESTING UNUSUALLY LOW ON THIS ONE ASSAY RUN. THE BIO-RAD TSR THEN CONTRACTED THE CUSTOMER AND ADVISED THE CUSTOMER TO RETEST THIS 0.220 OD SAMPLE. THE CUSTOMER RETESTED THE SAMPLE AND CONTACTED THE TECHNICAL SUPPORT DEPARTMENT FOUR DAYS LATER, TO REPORT THAT THE RETEST OF THE PREVIOUSLY NON-REACTIVE 0.220 OD SAMPLE PRODUCED A REACTIVE RESULT. THE CUSTOMER STATED THAT THE INITIAL RESULT OF NON-REACTIVE, BASED ON THE INITIAL 0.220 OD, WAS REPORTED TO THE PATIENT'S DOCTOR. A LABORATORIES DIAGNOSTIC SERVICE SPECIALIST WAS DISPATCHED TO THE DEPARTMENT OF HEALTH LABORATORY, AND OBSERVED THE PIPETTOR FUNCTION OF THE EVOLIS INSTRUMENT STRUGGLING TO ASPIRATE PATIENT SAMPLES FROM THE DILUTION PLATE INTO THE EIA MICROWELL PLATE. THE INITIAL INVESTIGATION INTO THIS ISSUE SUGGESTS THAT AN INSUFFICIENT QUANTITY OF SAMPLE MAY HAVE BEEN DISPENSED INTO THE EIA MICROWELL PLATE, RESULTING IN THE INITIAL SUPPRESSED 0.220 OD VALUE. THE EVOLIS IS DESIGNED TO PROVIDE ERROR MESSAGES, WHICH PREVENT REPORTING OF RESULTS FOR ANY SAMPLE FOR WHICH INCOMPLETE PROCESSING HAS OCCURRED. IN THIS INSTANCE, NO ERROR MESSAGE WAS PROVIDED TO INDICATE INSUFFICIENT SAMPLE OR REAGENT VOLUMES FOR THIS SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLIS MICROPLATE SYSTEM 4PS (FOUR PLATE SYSTEM) MZF STRATEC BIOMEDICAL SYSTEMS AG EVOLIS

    Patients

    Seq Age Sex Outcome Treatment
    1