BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M2000SP INSTRUMENT

    MDR report key: 862701 · Received June 8, 2007

    Report

    Report Number
    3005248192-2007-00001
    Event Type
    Malfunction
    Date Received
    June 8, 2007
    Date of Event
    May 10, 2007
    Report Date
    May 14, 2007
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    KEY
    Removal / Correction Number
    3005248192-06/06/07-002-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS RECENTLY BEEN IDENTIFIED THAT SPRING CLIPS ON DITI RACKS MAY HAVE SHARP PROTRUDING CORNERS. AFTER REMOVING THE DITI CAN FROM A DEVELOPMENTAL M2000SP, GLOVES WERE TORN AND THE FINGER SCRATCHED OF AN ABBOTT MOLECULAR EMPLOYEE. AN ADDITIONAL ABBOTT MOLECULAR EMPLOYEE CUT A FINGER WHILE WORKING ON A DITI CAN IN A MACHINE SHOP (NON-STANDARD USER ENVIRONMENT) ENOUGH TO DRAW BLOOD. THREE ADDITIONAL OBSERVATIONS OF SHARP EDGES WERE DOCUMENTED, ALTHOUGH THESE OBSERVATIONS DID NOT RESULT IN INJURY.

    Description of Event or Problem · 1

    AFTER A RECENT INTERNAL COMPANY COMPLAINT, IT HAS BEEN IDENTIFIED THAT SPRING CLIPS ON DISPOSABLE TIP (DITI) RACKS MAY HAVE SHARP PROTRUDING EDGES. IN THE ASSOCIATED COMPLAINT, AFTER REMOVING THE DITI RACK FROM A DEVELOPMENTAL VERSION OF THE M2000SP DURING EVALUATION, TESTING AND REMOVING THE TIPS FROM THE RACK, A GLOVE WAS TORN AND AN ABBOTT MOLECULAR EMPLOYEE'S FINGER WAS SCRATCHED. THIS OBSERVATION OF SHARP SPRING CLIP EDGES HAS NO EFFECT ON M2000SP OPERATION OR FUNCTIONALITY, AND NO IMPACT ON PATIENT RESULTS. THE SHARP EDGE OF THE DITI RACK'S SPRING CLIP MAY CAUSE PERSONAL INJURY OF A SCRATCH OR CUT. THIS INJURY CARRIES RISK OF INFECTION. THE EXPOSED SPRING CLIPS DO NOT NORMALLY CONTACT BIOHAZARDOUS MATERIAL, BUT ARE INSIDE THE INSTRUMENT IN CLOSE PROXIMITY TO POTENTIALLY BIOHAZARDOUS SUBSTANCES. WEEKLY DECONTAMINATION PROCEDURES ARE RECOMMENDED WITHIN THE OPERATIONS MANUAL MAINTENANCE PROCEDURES AND OPERATORS ARE TO BE TRAINED IN COMPLIANCE WITH GOOD LABORATORY PRACTICES AND GENERAL BIOHAZARD AND SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2000SP INSTRUMENT AUTOMATED SAMPLE PREPARATION SYSTEM KEY ABBOTT MOLECULAR, INC. MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 YR