BEUDAMED
    FDA Adverse Event Summary report: N

    ABBOTT M2000SP

    MDR report key: 2384682 · Received September 6, 2011

    Report

    Report Number
    3005248192-2011-00010
    Date Received
    September 6, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    JQW
    PMA / PMN Number
    K092705
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT MOLECULAR EVALUATED ALL FIVE 1 ML SUBSYSTEM CARRIERS USED AT THE CUSTOMER SITE. BELOW YOU WILL FIND A SUMMARY OF THE EVAL AND EXCERPTS FROM THE APPLICABLE LABELING. FIGURE 1 IS A PHOTOGRAPH OF THE GROOVED INNER EDGE OF THE 1ML SUBSYSTEM CARRIER WHERE THE ALLEGED INJURY TO THE OPERATOR'S FINGER OCCURRED. THERE IS A GROOVED EDGE OF BOTH SIDES OF THE 1ML SUBSYSTEM CARRIER WHERE THE COVER IS INSERTED. FIGURE 2 IS A PHOTOGRAPH OF THE ALLEGED INJURY TO THE FINGER OF THE OPERATOR. THE CUSTOMER WAS CONTACTED BY THE ABBOTT MOLECULAR APPLICATION SPECIALIST (MAS) WHO WAS INFORMED THAT THE INJURY DID NOT OCCUR DURING ROUTINE STEPS OF LOADING OR UNLOADING REACTION VESSELS. RATHER, THE INJURY OCCURRED WHILE THE CUSTOMER WAS CLEANING ONE OF THE 1ML SUBSYSTEM CARRIERS. THE CUSTOMER SUBSEQUENTLY SENT THE ALL FIVE 1ML SUBSYSTEM CARRIERS (B)(4) TO ABBOTT MOLECULAR FOR EVAL. THE DRAWING FOR THE 1ML SUBSYSTEM CARRIER (B)(4) WERE INSPECTED AND THE CARRIERS HAVE THE CORRECT DESIGN DIMENSIONS AND SHAPE. AS SHOWN IN THE SEQUENCE OF COVER INSTALLATION AND REMOVAL I FIGURE 3, THESE GROOVES ARE NOT CONTACTED BY THE USER DURING NORMAL OPERATION AND EDGES ARE DESIGNED TO AVOID INJURY. CONCLUSION: ADEQUATE USE AND CLEANING INSTRUCTIONS ARE AVAILABLE IN THE M2000SP OPERATIONS MANUAL. THE OPERATOR IS INSTRUCTED TO CLEAN THE 1ML SUBSYSTEM CARRIER BY SOAKING THE ASSEMBLY IN (B)(4) FOR APPROX 10 MINS. AFTER SOAKING THE CARRIER IS RINSED AND ALLOWED TO AIR DRY. BASED UPON THE AVAILABLE INFO, THE PRODUCT IS MEETING SPECS, AND THIS INCIDENT WAS DUE TO USER ERROR. APPLICABLE LABELING: THE M2000SP OPERATIONS MANUAL, (B)(4) 2009, CONTAINS WORKTABLE SETUP INFO IN SECTION 5. FIGURE 3 SHOWS APPROPRIATE PLACEMENT AND REMOVAL FOR THE 1ML SUBSYSTEM CARRIER COVER. THE OPERATOR IS NOT SUBJECTED TO SHARP EDGES ON THE CARRIER WHEN FOLLOWING THESE INSTRUCTIONS. SECTION 9 OF THE OPERATORS MANUAL INCLUDES THE FOLLOWING INSTRUCTIONS FOR CLEANING THE 1ML SUBSYSTEM CARRIER: CLEAN CARRIERS, RACKS, AND SPLASH FREE SUPPORT BASE SAMPLE RACKS AND THE 1 ML SUBSYSTEM CARRIER AND COVER, AND SPLASH FREE SUPPORT BASE CAN COME IN CONTACT WITH REAGENTS, SPECIMENS, CONTROLS, AND CALIBRATIONS. RESIDUES LEFT BEHIND MUST BE REMOVED. PERFORM THE FOLLOWING PROCEDURE TO CLEAN THE CARRIERS, RACKS, AND SUPPORT BASE. ITEMS TO BE CLEANED INCLUDE: SAMPLE RACKS; 1ML SUBSYSTEM CARRIER AND COVER, SOLID WASTE CHUTE, REAGENT VESSEL CARRIERS, DITI RACKS, DITI RACK CARRIERS, ASSAY REAGENT HOLDER ASSEMBLY, SPLASH FREE SUPPORT BASE. NOTE: THE 1 ML SUBSYSTEM CARRIER COVER AND THE SPLASH FREE SUPPORT BASE SHOULD BE CLEANED AFTER EVERY PROTOCOL RUN. REMOVE THE CARRIERS AND RACKS FROM THE M2000SP WORKABLE. REMOVE RESIDUE AND ANY APPLIED REAGENT OR SAMPLES WITH WATER OR A DETERGENT SOLUTION. SOAK IN (B)(4) SOLUTION FOR APPROX TEN MINUTES. RINSE THE CARRIERS AND RACKS COMPLETELY WITH WATER. AIR DRY THOROUGHLY.

    Description of Event or Problem · 1

    THE ABBOTT M2000 SYSTEM IS INTENDED FOR USE IN PERFORMING (B)(4) TESTING IN CLINICAL LABORATORIES. IT IS COMPRISED OF THE ABBOTT M2000SP AND THE ABBOTT (B)(4) INSTRUMENTS. THE ABBOTT M2000SP IS AN AUTOMATED SYSTEM FOR PERFORMING SAMPLE PREPARATION FOR (B)(4) TESTING. AN M2000SP OPERATOR IN (B)(4) INFORMED ABBOTT MOLECULAR THAT SHE HAD CUT HER FINGER THROUGH THE GLOVE ON THE INSIDE SURFACE OF THE GROOVE FOR THE TOP COVER ON THE 1ML. SUBSYSTEM CARRYOVER DURING THE CLEANING PROCEDURE. THE CUSTOMER LET THE BLOOD FLOW FROM HER BLEEDING FINGER FOR A WHILE. THEN SHE APPLIED A DISINFECTION SOLUTION SEVERAL TIMES AND APPLIED A BAND-AID. AS THE CARRIERS WERE DISINFECTED BEFORE SHE CUT HER FINGER, SHE DOES NOT THINK THAT SHE GOT ANYTHING AND IS NOT GOING TO GET ANY SPECIAL TREATMENT. THE LAB CONDUCTS REGULAR TESTING IN HOUSE AND SO FAR EVERYTHING IS FINE. THE CUSTOMER HAS BEEN VACCINATED FOR (B)(6) AND (B)(6), AND HER ANTIBODY TITERS ARE HIGH ENOUGH.

    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