BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDXFLX VANCOMYCIN REAGENT

    MDR report key: 1170271 · Received September 24, 2008

    Report

    Report Number
    2623532-2008-00019
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    September 6, 2008
    Report Date
    September 8, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS INT'L, LTD
    Product Code
    LEH
    PMA / PMN Number
    K812318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ALTHOUGH RETURNED MATERIAL WAS NOT AVAILABLE FOR THE INVESTIGATION FROM THE CUSTOMER SITE, SAMPLES STORED AT ABBOTT WERE INSPECTED AND TESTED. NO DISCREPANCY WAS SEEN DURING INSPECTION. THE BARCODE LABEL OF THE STORED SAMPLES READ CORRECTLY THREE TIMES ON EACH OF TWO TDX INSTRUMENTS. IN ADDITION, SAMPLES STORED AT ABBOTT WERE INSPECTED AND TESTED ON TWO TDXFLX INSTRUMENTS FROM A PREVIOUS INVESTIGATION. THIS PREVIOUS INVESTIGATION WAS COMPLETED FOR THE SAME TDX/TDXFLX VANCOMYCIN REAGENT LOT 53435Q100 AND FOR A BARCODE ERRORS/DEFECT ISSUE. NO DISCREPANCY WAS SEEN DURING THE INSPECTION. THE BARCODE LABEL OF THE STORED SAMPLES ALSO READ CORRECTLY THREE TIMES ON EACH OF TWO TDXFLX INSTRUMENTS. A REVIEW WAS ALSO COMPLETED OF ASSOCIATED COMPLAINTS. THE TRACKING DATA INCLUDED A REVIEW OF ADDITIONAL COMPLAINTS FOR THIS ASSAY AND WERE NOT INDICATIVE OF A PRODUCT SPECIFIC ISSUE. NO ISSUES RELATED TO BARCODE ERRORS/DEFECTS WERE IDENTIFIED FOR THE PRODUCT OR SPECIFIC LOT DOCUMENTED IN THE CUSTOMER'S COMPLAINT. THE CUSTOMER'S ISSUE IS ADDRESSED IN THE TDX SYSTEM OPERATIONS MANUAL, OPERATION, BARCODE OVERRIDE SUBSECTION PAGE 3-43. THE RESULTS OF THIS INVESTIGATION WERE EVALUATED AND NO ADDITIONAL ISSUES WERE IDENTIFIED. BASED ON A REVIEW OF THE RESULTS OF THIS INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. NO ADDITIONAL INFORMATION NEEDS TO BE GIVEN TO ASSIST THE CUSTOMER OTHER THAN TO FOLLOW THE INSTRUMENT OPERATIONS MANUAL AND/OR CONTACT CUSTOMER SERVICE AND SUPPORT. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE TDX ANALYZER MISREAD THE REAGENT BARCODE LABEL OF THE VANCOMYCIN ASSAY AS "CYB-MATHAB-WB." RESULTS OF 0.0 MG/L WERE REPORTED OUT OF THE LAB BY THE TECHNICIAN THINKING THAT THEY WERE VANCOMYCIN RESULTS. ANOTHER TECHNICIAN LATER NOTICED THE MISREAD ASSAY NAME AND THE SAMPLE WAS RETESTED AT A VALUE OF 5.8 MG/L. THE CUSTOMER STATES THAT THERE WERE NO ISSUES WITH READING THE BARCODE LABEL OF THIS REAGENT PACK EITHER BEFORE OR AFTER THIS PARTICULAR EVENT OCCURRED. THE CUSTOMER RUNS CONTROLS ONLY ONCE PER DAY. THERE IS NO OTHER INFORMATION PROVIDED AS TO ANY IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TDXFLX VANCOMYCIN REAGENT QUANTITATIVE MEASUREMENT OF VANCOMYCIN IN SERUM AND PLASMA LEH ABBOTT DIAGNOSTICS INT'L, LTD NA 60473Q100

    Patients

    Seq Age Sex Outcome Treatment
    1 TDX ANALYZER LN:9520