BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TDX FPIA ANALYZER

    MDR report key: 1299143 · Received February 2, 2009

    Report

    Report Number
    1628664-2009-00056
    Event Type
    Injury
    Date Received
    February 2, 2009
    Date of Event
    January 25, 2009
    Report Date
    January 29, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJQ
    PMA / PMN Number
    K811263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT TEXT INDICATES THE CUSTOMER OPENED THE LID OF THE TDX ANALYZER TO REMOVE A GENTAMICIN REAGENT KIT AND THE TOP OF THE LEFT MIDDLE FINGER HIT THE PROBE. THE PROBE WAS STATIONARY AT THIS TIME. THE OPERATOR PERFORMED FIRST AID BY REMOVING THE GLOVE, SQUEEZING THE WOUND TO ENCOURAGE BLEEDING AND RAN THE FINGER UNDER RUNNING TAP WATER. FOLLOWING LAB POLICY, THE OPERATOR OBTAINED MEDICAL ATTENTION. FOLLOWUP INDICATES THE WOUND IS LOOKING FINE AND SHOWING NO SIGNS OF INFECTION. THE SAMPLE RUN PRIOR TO THE INCIDENT WAS FROM A KNOWN HOMOSEXUAL PATIENT WITH A NEGATIVE RESULT AT LAST TEST. A REVIEW OF THE SERVICE HISTORY OF TDX ANALYZER INDICATES THERE WERE NO OTHER INJURY COMPLAINTS SINCE THE INITIATION OF THIS COMPLAINT. A REVIEW WAS ALSO PERFORMED OF THE COMPLAINT DATABASE FOR THE TIME PERIOD OF 2008 - 2009 AND FOUND NO SIMILAR COMPLAINTS FOR THE CUSTOMER DESCRIBED ISSUE. THE CUSTOMER'S ISSUE IS ADDRESSED IN THE TDX SYSTEM OPERATION MANUAL WHICH CONTAINS ADEQUATE INFORMATION IN REGARDS TO THIS ISSUE. THE INVESTIGATION DEMONSTRATED THAT THE TDX FPIA ANALYZER IS PERFORMING WITHIN ITS INTENDED USE, LABEL CLAIMS AND SPECIFICATIONS. OPERATOR ERROR IS THE MOST PROBABLE CAUSE OF THIS CUSTOMER DESCRIBED ISSUE. NO DEFICIENCY RELATED TO THE PERFORMANCE OF THE DEVICE WAS IDENTIFIED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT WHILE REMOVING A REAGENT PACK FROM THE TDX ANALYZER, SHE SCRATCHED THE BACK OF HER MIDDLE FINGER OF HER LEFT HAND WITH THE SAMPLE PROBE. THE PROBE RIPPED THROUGH THE GLOVE SHE WAS WEARING AND BROKE THE SKIN OF THE FINGER. THE CUSTOMER WAS PLACED A COURSE OF "PEP" ANTIBIOTICS (PREVENTIVE TREATMENT) WITH BLOOD SAMPLES TAKEN FOR HEPATITIS AND TESTING. THE CUSTOMER HAS EXPERIENCED NAUSEA AND DIARRHEA AS A RESULT OF THE ANTIBIOTICS. THE CUSTOMER STATES THAT A HIGH RISK PATIENT SAMPLE WAS TESTED THAT DAY AND INQUIRED ABOUT THE SAMPLE PROBE WASHING AND SAMPLE VOLUME USED BY THE ANALYZER. THERE IS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TDX FPIA ANALYZER AUTOMATED FLUORESCENT IMMUNOASSAY ANALYZER JJQ ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention