BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT M2000SP

    MDR report key: 2367693 · Received May 8, 2011

    Report

    Report Number
    3005248192-2011-00004
    Event Type
    Injury
    Date Received
    May 8, 2011
    Date of Event
    April 11, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JQW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER FAILED TO FOLLOW GOOD LAB PRACTICES AND THE INSTRUCTIONS OF THE INSTRUMENT. THE APPROPRIATE LABELING FOR THE M2000SP CAN BE FOUND BELOW: LABELING: M2000SP OPERATIONS MANUAL SOFTWARE VERSION 4.0 (200680-104/SEPTEMBER 2009) INCLUDES INSTRUCTIONS FOR SPILL CLEAN UP AND INSTRUCTIONS FOR HANDLING BIOLOGICAL HAZARDS: SPILL CLEANUP. CLEAN SPILLS IN ACCORDANCE WITH ESTABLISHED BIOSAFETY PRACTICES AND FOLLOW INSTRUCTIONS PROVIDED IN THE MSDS. IN GENERAL, SAFE WORK PRACTICES FOR CLEANING SPILLS INCLUDE THE FOLLOWING PROCEDURES: WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT SUCH AS GLOVES EYEWEAR AND LAB COATS. ABSORB THE SPILL WITH ABSORBENT MATERIAL. WIPE THE SPILL AREA WITH DETERGENT SOLUTION. WIPE THE AREA WITH AN APPROPRIATE DISINFECTANT SUCH AS 1% SODIUM HYPOCHLORITE. BIOLOGICAL HAZARDS: THE FOLLOWING ACTIVITIES MAY INVOLVE THE PRESENCE OF BIOLOGICAL MATERIALS: HANDLING SAMPLES REAGENTS CALIBRATIONS AND CONTROLS, CLEANING SPILLS, HANDLING AND DISPOSING OF WASTE, MOVING THE INSTRUMENT, PERFORMING MAINTENANCE PROCEDURES, PERFORMING DECONTAMINATION PROCEDURES, PERFORMING COMPONENT REPLACEMENT PROCEDURES. PRECAUTIONS: CONSIDER ALL CLINICAL SPECIMENS REAGENTS, CONTROLS AND CALIBRATORS THAT CONTAIN HUMAN-SOURCED MATERIAL AND INSTRUMENT SURFACES OR COMPONENTS THAT HAVE COME IN CONTACT WITH HUMAN-SOURCED MATERIAL AS POTENTIALLY INFECTIOUS. NO KNOWN TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT PRODUCTS DERIVED FROM HUMAN-SOURCED MATERIAL OR INSTRUMENT COMPONENTS CONTAMINATED WITH THESE MATERIALS WILL NOT TRANSMIT INFECTION. THEREFORE, ALL PRODUCTS DERIVED FROM HUMAN-SOURCED MATERIALS AND CONTAMINATED INSTRUMENTS SHOULD BE CONSIDERED POTENTIALLY INFECTIOUS. IT IS RECOMMENDED THAT ALL POTENTIALLY INFECTIOUS MATERIALS BE HANDLED IN ACCORDANCE WITH THE OSHA STANDARD ON BLOODBORNE PATHOGENS. BIOSAFETY LEVEL 2 OR OTHER APPROPRIATE BIOSAFETY PRACTICES SHOULD BE USED FOR MATERIALS THAT CONTAIN OR ARE SUSPECTED OF CONTAINING INFECTIOUS AGENTS. PRECAUTIONS INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING: WEAR GLOVES, LAB COATS AND PROTECTIVE EYEWEAR WHEN HANDLING HUMAN-SOURCED MATERIAL OR CONTAMINATED INSTRUMENT COMPONENTS. DO NOT PIPET BY MOUTH. DO NOT EAT, DRINK, SMOKE, APPLY COSMETICS OR HANDLE CONTACT LENSES IN THE SAME AREA WHERE HUMAN-SOURCED MATERIAL OR CONTAMINATED INSTRUMENT COMPONENTS ARE HANDLED. CLEAN SPILLS OF POTENTIALLY INFECTIOUS MATERIALS AND CONTAMINATED INSTRUMENT COMPONENTS WITH A DETERGENT SOLUTION FOLLOWED BY AN APPROPRIATE DISINFECTANT SUCH AS 1% SODIUM HYPOCHLORITE. OPERATORS EXPOSED TO BIOHAZARDOUS OR POTENTIALLY INFECTIOUS MATERIALS SHOULD TAKE STEPS IMMEDIATELY TO CLEANSE THE AFFECTED AREA AS SUGGESTED BELOW. TABLE 8.2: CLEANSING PROCEDURES FOR BIOHAZARDOUS EXPOSURE. EYES: RINSE WITH WATER FOR 15 MINUTES; MOUTH: RINSE WITH WATER; SKIN: WASH THE AFFECTED AREA WITH SOAP AND WATER; PUNCTURE WOUND: ALLOW WOUND BLEED FREELY, WASH THE AFFECTED AREA WITH SOAP AND WATER, SEEK MEDICAL TREATMENT.

    Description of Event or Problem · 1

    THE ABBOTT M2000 SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID TESTING IN CLINICAL LABORATORIES. IT IS REPORTED OF THE ABBOTT M2000SP AND THE ABBOTT M2000RT INSTRUMENTS. THE ABBOTT M2000SP IS AN AUTOMATED SYSTEM FOR PERFORMING SAMPLE PREPARATION FOR NUCLEIC ACID TESTING. THE ABBOTT M2000RT IS AN AUTOMATED SYSTEM FOR PERFORMING FLUORESCENCE-BASED PCR TO PROVIDE QUANTITATIVE AND QUALITATIVE DETECTION OF NUCLEIC ACID SEQUENCES. CUSTOMER WAS USING THE M2000SP ON OPEN MODE AND PROCESSED 13 SAMPLES. AT THE END OF THE RUN, WHILE CLEANING THE HEATER ZONE 1, SHE ACCIDENTALLY HAD A SPILL AND SOME GOT INTO HER EYE. THE SAMPLE THAT SHE CAME INTO CONTACT WITH IS (B)(6) AND THE LAST VIRAL LOADS ARE FROM (B)(6) 2011 AND WERE (B)(6). THE SAMPLES WERE BEING TESTED TO (B)(6) USING RNA 500-70 EXTRACTION PROTOCOL AND A LAB DEVELOPED ASSAY (LDA) AMPLIFICATION/DETECTION PROTOCOL. CUSTOMER WENT TO THE DOCTOR AND IS NOW ON (B)(6) THERAPY; (B)(6). CUSTOMER WILL BE ON (B)(6) THERAPY (B)(6) FOR 1 MONTH. CUSTOMER WAS WEARING GLOVES, LAB COAT, BUT SHE WAS NOT WEARING SAFETY GOGGLES. CUSTOMER USES SAFETY GOGGLES TO SEPARATE SAMPLES, BUT SHE FORGOT TO PUT THEM ON WHEN CLEANING THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT M2000SP STATION, PIPETTING AND DILUTING, FOR CLINICAL USE, PRODUCT CODE: JQW JQW ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1