BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLIS MICROPLATE SYSTEM

    MDR report key: 1279650 · Received December 17, 2008

    Report

    Report Number
    3022521-2008-00008
    Event Type
    Malfunction
    Date Received
    December 17, 2008
    Date of Event
    November 1, 2008
    Report Date
    November 20, 2008
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE #1 REAGENT RACK IS A REMOVABLE COMPONENT OF THE EVOLIS, DESIGNED TO ALLOW LOADING OF THE REAGENT CONTAINERS AWAY FROM THE EVOLIS. ONCE LOADED, THE REAGENT RACK IS INSERTED INTO THE EVOLIS FOR PROCESSING. THE #1 REAGENT RACK IS SILVER IN COLOR AND 16" LONG BY 2" TALL BY 1 1/2" WIDE. THERE ARE 12 INDIVIDUAL REAGENT POSITIONS LABELED A-L. THE CUSTOMER'S RACK WAS REC'D WITH DAMAGE TO THE CONTAINER SPRINGS IN POSITION A, B, E, F, H, J, K AND L, WITH THE DAMAGE TO THE A POSITION BEING THE MOST SEVERE AND THE MOST LIKELY SOURCE OF INJURY. THE SPRING IN POSITION A PROTRUDES OUT OF THE RACK APPROX 3/8". THE REST OF THE RACK APPEARS IN GOOD CONDITION, WITH NO ABNORMAL WEAR AND LACKING ANY SIGN OF CORROSION OR SPILT REAGENTS. ALL DAMAGED SPRINGS EXHIBIT THE SAME FORM OF DEFORMATION. THIS DEFORMATION IS DUE TO THE SPRINGS BEING CAUGHT ON REAGENT CONTAINER LABELS AS THE CONTAINERS ARE TWISTED, IN THE RACK, TO PLACE THE REAGENT BARCODES IN THE CORRECT ORIENTATION.

    Description of Event or Problem · 1

    BIO-RAD LABORATORIES RECEIVED A PHONE CALL IN 2008 FROM THE BIO-RAD LABORATORIES SALES TECHNICAL SERVICES. HE REPORTED THE CUSTOMER HAD AN EVOLIS REAGENT RACK WITH A DAMAGED SPRING CLIP THAT HAD CUT A LAB TECHNICIAN'S FINGER. THE EVOLIS IS A 4-PLATE SELF-CONTAINED MICROPLATE PROCESSOR SYSTEM DESIGNED FOR USE WITH MULTIPLE EIA ASSAYS. BIO-RAD LABORATORIES TECHNICAL SERVICE REP CALLED, AND SPOKE WITH THE CUSTOMER CONTACT WHO CONFIRMED THE LAB TECHNICIAN HAD CUT HER FINGER ON THE EXPOSED SHARP EDGE OF THE DAMAGED SPRING CLIP WHILE SLIDING THE RACK ONTO THE EVOLIS DECK WHEN LOADING A RUN FOR PROCESSING. THE CUT WAS TREATED IN THE LAB WITH FIRST AID AND BANDAGE. NO FURTHER MEDICAL ATTENTION WAS SOUGHT. THE RACK WAS RETURNED TO BIO-RAD LABORATORIES, AND THE CUSTOMER RECEIVED A NEW EVOLIS REAGENT RACK. SUBSEQUENT EVALUATION OF THE RACK DETERMINED DAMAGE TO THE A-POSITION SPRING TO BE THE MOST LIKELY SOURCE OF INJURY, AND WAS LIKELY CAUSED BY TWISTING THE REAGENT CONTAINER INTO THE RACK.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1