BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT M2000SP

    MDR report key: 2918184 · Received January 16, 2013

    Report

    Report Number
    3005248192-2013-00001
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 28, 2012
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JJH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THIS MDR 3005248192-2013-00001 FOLLOW-UP REPORT 1 IS TO PROVIDE AN UPDATE ON THE OUTCOME OF THE CUSTOMER'S TEST RESULTS FROM BEING MONITORED FOR POTENTIAL VIRUSES (B)(6). ON (B)(6) 2013, THE ABBOTT MOLECULAR FIELD APPLICATION SPECIALIST CALLED THE CUSTOMER TO INQUIRE ABOUT THE STATUS OF HER MONITORED TEST RESULTS. THE CUSTOMER STATED THAT HER TEST RESULTS FOR (B)(6) WERE (B)(6).

    Additional Manufacturer Narrative · 1

    THE M2000SP OPERATIONS MANUAL (200681-105-OCTOBER 2011) INCLUDES THE FOLLOWING PRECAUTIONS AND WARNINGS TO GUARD AGAINST ACCIDENTAL BIOHAZARD EXPOSURE : USER OR FUNCTION - CABINET-LIQUID WASTE CONTAINER CAUTION: THE WASTE IS POTENTIALLY INFECTIOUS. USE APPROPRIATE BIOHAZARD PRECAUTIONS. HAZARDS - WASTE HANDLING AND DISPOSAL- LIQUID WASTE WARNING: THE LIQUID WASTE MAY CONTAIN INFECTIOUS AGENTS AND SHOULD BE CONSIDERED POTENTIALLY INFECTIOUS WASTE. SERVICE AND MAINTENANCE - DAILY MAINTENANCE- EMPTY LIQUID WASTE CONTAINER WARNING: POTENTIAL BIOHAZARD. INSTRUMENT WASTE COULD BE CONTAMINATED WITH POTENTIALLY INFECTIOUS MATERIALS. OBSERVE BASIC BIOHAZARD PRECAUTIONS WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT SUCH AS GLOVES, LAB COATS, AND PROTECTIVE EYEWEAR. HAZARDS-BIOLOGICAL HAZARDS-PRECAUTIONS WEAR GLOVES, LAB COATS, AND PROTECTIVE EYEWEAR WHEN HANDLING HUMAN SOURCES MATERIAL OR CONTAMINATED INSTRUMENT COMPONENTS. WE WILL SUBMIT A FOLLOW-UP REPORT WHEN WE RECEIVE AN UPDATE ON THE CUSTOMER'S MEDICAL CONDITION. CUSTOMER FAILED TO FOLLOW PROCEDURE.

    Description of Event or Problem · 1

    THE ABBOTT M2000SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID TESTING IN CLINICAL LABORATORIES. IT IS COMPRISED OF THE ABBOTT M2000SP AND ABBOTT M2000RT INSTRUMENTS. THE ABBOTT M2000SP INSTRUMENT IS AN AUTOMATED FLUID HANDLING SYSTEM FOR PERFORMING SAMPLE PREPARATION FOR NUCLEIC SAMPLE TESTING. THE ABBOTT M2000RT SYSTEM SOFTWARE IS AN AUTOMATED SYSTEM FOR PERFORMING FLUORESCENCE-BASED PCR THAT RESULTS IN QUANTITATIVE AND QUALITATIVE DETECTION OF NUCLEIC ACID SEQUENCES. ACCIDENTAL EXPOSURE TO POTENTIALLY BIOHAZARDOUS MATERIAL OCCURRED WHEN LIQUID WASTE SPLASHED ON THE FACE OF A CUSTOMER AS SHE WAS RECONNECTING THE WASTE CONTAINER AFTER EMPTYING IT. THIS COULD RESULT IN SERIOUS INJURY AS THE LIQUID WASTE IS POTENTIALLY INFECTIOUS. THIS LAB ROUTINELY PERFORMS REALTIME HIV, REALTIME HCV, AND REALTIME HBV TESTING. THE CUSTOMER RECEIVED A TRI-THERAPY POST-EXPOSURE TREATMENT FOR 3 DAYS, AND WILL HAVE A FOLLOW-UP FOR MONITORING POTENTIAL VIRUSES HIV, HCV AND HBV. THE CUSTOMER DID NOT FOLLOW THE GOOD LABORATORY PRACTICE OF WEARING PROTECTIVE EYEWEAR AS A BASIC BIOHAZARD PRECAUTION, AND DID NOT FOLLOW THE WARNINGS AND PRECAUTIONS IN THE M2000SP OPERATOR'S MANUAL 200681-105-OCTOBER 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23932 ABBOTT M2000SP CLINICAL SAMPLE CONCENTRATOR JJH ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other