BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT M2000SP

    MDR report key: 2367662 · Received May 18, 2011

    Report

    Report Number
    3005248192-2011-00006
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JQW
    PMA / PMN Number
    K092705
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH THE OPERATING MANUAL AND THE ASSAY PACKAGE INSERT INSTRUCT USERS TO TAKE NECESSARY PRECAUTIONS. BELOW YOU WILL FIND THE APPLICABLE LABELING. M2000SP OPERATIONS MANUAL SOFTWARE VERSION 4.0 (200681-104 SEPTEMBER 2009) INCLUDES A DESCRIPTION OF THE DEEP WELL PLATES IN THE REUSE POSITION AND HOW TO REMOVE AFTER USE." M2000SP OPERATIONS MANUAL SOFTWARE VERSION 4.0 (200681-104 I SEPTEMBER 2009) INCLUDES INSTRUCTIONS FOR HANDLING 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 CALIBRATION 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. REALTIME HIV-1 ASSAY PACKAGE INSERT (51-602100/R5) INCLUDES INSTRUCTIONS FOR SAFETY PRECAUTIONS: SAFETY PRECAUTIONS: REFER TO THE ABBOTT M1000 OPERATING MANUAL, SAFETY SECTION, THE MANUAL SAMPLE PREPARATION FOR ABBOTT REALTIME RNA ASSAYS PROCEDURE, HANDLING PRECAUTION SECTION, OR ABBOTT M2000SP AND ABBOTT M2000RT OPERATIONS MANUALS, HAZARD SECTION, FOR INSTRUCTIONS ON SAFETY PRECAUTIONS. CAUTION: THIS PRODUCT CONTAINS HUMAN SOURCED AND/OR POTENTIALLY INFECTIOUS COMPONENTS. FOR A SPECIFIC LISTING, REFER TO THE REAGENTS SECTION OF THIS PACKAGE INSERT. HUMAN SOURCED MATERIAL HAS BEEN TESTED AND FOUND TO BE (B)(6). NO KNOWN TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT PRODUCTS DERIVED FROM HUMAN SOURCES OR INACTIVATED MICROORGANISMS WILL NOT TRANSMIT INFECTION. THEREFORE, ALL HUMAN SOURCED MATERIALS SHOULD BE CONSIDERED POTENTIALLY INFECTIOUS. IT IS RECOMMENDED THAT THESE REAGENTS AND HUMAN SPECIMENS BE HANDLED IN ACCORDANCE WITH THE OSHA STANDARD ON BLOODBORNE PATHOGENS. BIOSAFETY LEVEL 2 OF OTHER APPROPRIATE BIOSAFETY PRACTICES SHOULD BE USED FOR MATERIALS THAT CONTAIN OR ARE SUSPECTED OF CONTAINING INFECTIOUS AGENTS. THESE PRECAUTIONS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: WEAR GLOVES WHEN HANDLING SPECIMENS OR REAGENTS. DO NOT PIPETTE BY MOUTH. DO NOT EAT, DRINK, SMOKE, APPLY COSMETICS, OR HANDLE CONTACT LENSES IN AREAS WHERE THESE MATERIALS ARE HANDLED. CLEAN AND DISINFECT SPILLS OF SPECIMENS BY INCLUDING THE USE OF A TUBERCULOCIDAL DISINFECTANT SUCH AS 1.0% SODIUM HYPOCHLORITE OR OTHER SUITABLE DISINFECTANT.

    Description of Event or Problem · 1

    THE ABBOTT M2000 SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID TESTING IN CLINICAL LABORATORIES. IT IS COMPRISED 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 CLEANING THE INSTRUMENT, A M2000SP ABBOTT AUTOMATED FLUID HANDLING SYSTEM E-SERIES AFTER A RUN. WHILE TAKING OUT THE DEEP WELL PLATE FROM THE REUSE POSITION (WHILE RUNNING REALTIME HIV-1, 0.6 ML), IT SLIPPED OUT OF HER HAND. THE LIQUID SPLASHED IN THE AIR AND SHE FELT THE LIQUID UNDERNEATH THE SAFETY GOGGLES ON THE SKIN SURROUNDING HER EYES. CUSTOMER WAS NOT SURE WHETHER SOME LIQUID ADDITIONALLY GOT INTO THE EYES. CUSTOMER WAS WEARING GOGGLES, GLOVES, AND A LABCOAT. THE EYES WERE WASHED IMMEDIATELY WITH AN EYE SHOWER FOR 15 MIN. A DOCTOR WAS CONTACTED AND SHE WAS PLACED ON PROPHYLACTIC THERAPY. ONE DAY AFTER THE EXPOSURE, A 2ND PHYSICIAN WAS CONTACTED TO FURTHER DISCUSS HOW TO PROCEED. THE PHYSICIAN INDICATED THE RISK OF INFECTION UNDER THESE CIRCUMSTANCES IS VERY LOW, BUT THE CUSTOMER WANTED TO BE TREATED. INCIDENT WAS REPORTED TO THE COMMISSIONER OF THE UNIVERSITY. THE LIQUID THAT CAN BE FOUND IN THE DEEP WELL PLATE OF THE REUSE POSITION CONSISTS OF VARIOUS REAGENTS INCLUDING SOME DROPS OF THE SAMPLES AS WELL AS LYSIS BUFFER.

    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. 09K14-002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other