BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TDXFLX SYSTEM

    MDR report key: 1220550 · Received November 6, 2008

    Report

    Report Number
    1628664-2008-00251
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    May 8, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJQ
    PMA / PMN Number
    K904226
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS CLEANING THE BARCODE READER ON THE ABBOTT TDXFLX ANALYZER AND HER HAND SLIPPED AND WAS SCRATCHED BY THE ANALYZER'S SAMPLING PROBE. THE CUSTOMER WAS WEARING GLOVES AT THE TIME OF THE EVENT. SHE WAS SEEN BY THE EMERGENCY ROOM PHYSICIAN. THE PHYSICIAN CLASSIFIED THE INJURY AS A SCRATCH NOT A PUNCTURE. THE CUSTOMER WAS GIVEN A TETANUS SHOT. BECAUSE THE INJURY WAS CLASSIFIED AS A SCRATCH NOT A PUNCTURE WOUND, THE CUSTOMER WAS TOLD SHE DID NOT HAVE TO HAVE PROPHYLACTIC TREATMENT. SHE WAS GIVEN THE OPTION TO HAVE THE SHOTS. THE CUSTOMER DECLINED THE TREATMENT. BLOOD WAS DRAWN FOR BASELINE TESTING. FOLLOWUP WITH THE CUSTOMER IN 2008 INDICATES THE CUSTOMER IS ATTENDING SAFETY TRAINING AND SHE IS FEELING FINE. A REVIEW OF THE SERVICE HISTORY RECORDS INDICATES THERE WERE NO OTHER INJURY COMPLAINTS SINCE THE INITIATION OF THIS COMPLAINT. THE CUSTOMER'S ISSUE IS ADDRESSED IN THE TDXFLX SYSTEM OPERATION MANUAL, SYSTEM DESCRIPTION, OPERATIONAL PRECAUTIONS AND LIMITATIONS, WHICH PROVIDES CAUTIONS AND WARNINGS WHEN PERFORMING MAINTENANCE AND RUNNING THE ANALYZER. SECTION 5, MAINTENANCE, PERIODIC HAZARDS, PROVIDES INSTRUCTIONS FOR CLEANING THE BARCODE READER. WITH THE AVAILABLE INFORMATION, A DEFICIENCY OF THE TDXFLX SYSTEM WAS NOT IDENTIFIED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT WAS CORRECTED FROM (B)(6) 2000 TO (B)(6) 2008.

    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 CLEANING THE BARCODE READER ON THE TDXFLX ANALYZER HER HAND SLIPPED AND THE SAMPLE PROBE/FLUID SENSING ELECTRODE ASSEMBLY SCRATCHED HER HAND. THE CUSTOMER RECEIVED A TETANUS SHOT AND BLOOD WAS DRAWN FOR FURTHER WORK-UP. THERE IS NO FURTHER IMPACT TO THE OPERATOR REPORTED.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THERE ARE BLUE AND GREEN MARKS ON THE METER'S DISPLAY. THE REPORTED ISSUE WAS UNRESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention