CLINICAL CHEMISTRY IRON

Additional Manufacturer Narrative

(B)(4). THE COMPLAINT TEXT (B)(4) STATES THE CUSTOMER IS OBSERVING IRON RESULTS WHICH ARE LOWER WHEN COMPARED WITH RESULTS RUN ON THE OLYMPUS AND BAYER ANALYZER. ONE SERUM SAMPLE WAS RUN ON THE ARCHITECT C8000 WITH A RESULT OF 8 AND THEN ON THE OLYMPUS WITH A RESULT OF 62. ANOTHER SAMPLE WAS RUN ON THE ARCHITECT C8000 WITH A RESULT OF 6, AND THEN REPEATED ON THE BAYER WITH A RESULT OF 63. THE CUSTOMER IS USING CLINICAL CHEMISTRY IRON REAGENT LOT 62037HW00, WITH IRON/MG CALIBRATOR LOT 54187M200. THE CUSTOMER IS USING MULTIQUAL CONTROLS (LOT NUMBER 45550) WHICH WERE IN RANGE. THE INVESTIGATION INDICATES THE LOT RELEASE DATA CONTAINED IN THE CERTIFICATE OF ANALYSIS FOR IRON REAGENT LOT 62037HW00 DID NOT INDICATE ANY ISSUE WITH REAGENT PERFORMANCE. REVIEW OF THE CUSTOMERS CALIBRATION CURVE VALUES FOUND THEY WERE SIMILAR TO VALUES FROM IRON CALIBRATIONS PRODUCED DURING 2005 AND 2006 (B)(6) SAMPLE TESTING. IN ADDITION, THE MULTIQUAL CONTROL VALUES FOR LOT 45550 WERE WITHIN THE CUSTOMERS RANGES. THE 2006-2008 (B)(6) SUMMARY RESULTS FOR IRON DEMONSTRATED THAT THE ARCHITECT SYSTEM (AEROSET AND ARCHITECT RESULTS COMBINED IN 2007) SHOWED AN AVERAGE BIAS OF 3.3% VERSUS THE ALL METHOD MEAN (AMM). OLYMPUS INSTRUMENTS SHOWED AN AVERAGE BIAS OF +5.6% VERSUS THE ALL METHOD MEAN. BAYER SIEMENS, USING THE NITROSO PSAP METHODOLOGY BEGINNING IN 2008) SHOWED AN AVERAGE BIAS OF +1.7% VERSUS THE AMM. THE AVERAGE BIAS CALCULATED FROM THE (B)(6) 2006 GENERAL CHEMISTRY SURVEY C-A OLYMPUS IRON RESULTS THROUGH THE (B)(6) 2008 GENERAL CHEMISTRY SURVEY C-B OLYMPUS IRON RESULTS, COMPARED TO THE ARCHITECT RESULTS FROM THE SAME TIME PERIOD IS +9.2%. THE AVERAGE BIAS CALCULATED FROM 2006 GENERAL CHEMISTRY SURVEY C-C BAYER ADVIA IRON RESULTS THROUGH THE CAP 2008 GENERAL CHEMISTRY C-B BAYER (SIEMENS) ADVIA IRON RESULTS, COMPARED TO THE ARCHITECT RESULTS FROM THE SAME TIME PERIOD IS +5.2%. THIS BIAS IS PROBABLY DUE TO THE DIFFERENT METHODOLOGIES USED FOR EACH CLINICAL CHEMISTRY SYSTEM. AS DETERMINED FROM THE FOR THE 2008 C-B CHEMISTRY/TDM CAP PARTICIPANT SUMMARY, THE OLYMPUS AND BAYER ADVIA (SIEMENS) HAVE A VARIETY OF POSSIBLE METHODOLOGIES THAT ARE USED TO PRODUCE IRON RESULTS, SUCH AS OLYMPUS NITROSO PSAP, FERROCHROME WITHOUT PRIOR PROTEIN REMOVAL, AND TPZ WITHOUT PRIOR PROTEIN REMOVAL. CLINICAL CHEMISTRY IRON REAGENT USES THE FERENE WITHOUT PRIOR PROTEIN REMOVAL METHODOLOGY. THIS METHOD PRODUCED LOWER RESULTS THAN THE FERROCHROME W/O PPR, TPZ W/O PPR, AND THE OLYMPUS NITROSO PSAP, FOR EACH SAMPLE IN THE (B)(6) SURVEY. THE BAYER ADVIA SYSTEMS USED THE FERROZINE WITHOUT PRIOR PROTEIN REMOVAL METHODOLOGY UNTIL 2008, AND THEN BEGAN USING THE NITROSO PSAP METHODOLOGY. THE OLYMPUS INSTRUMENTS USE THE NITROSO PSAP METHODOLOGY. NEITHER BAYER ADVIA (SIEMENS) NOR OLYMPUS INSTRUMENTS USE FERENE WITHOUT PRIOR PROTEIN REMOVAL. THE PACKAGE INSERTS FOR BAYER AND OLYMPUS IRON REAGENTS LIST SERUM AND PLASMA AS SUITABLE SPECIMENS. THERE IS NO PLASMA CLAIM FOR CLINICAL CHEMISTRY IRON (B)(4). A SEARCH FOR SIMILAR COMPLAINTS IN THE COMPLAINT ANALYSIS TRENDING SYSTEM (CATS) DATABASE WAS DONE AND THIS WAS THE ONLY COMPLAINT FOR THIS LOT OF IRON REAGENT GENERATING IRON RESULTS WHICH ARE LOWER WHEN COMPARED WITH RESULTS RUN ON THE OLYMPUS AND BAYER ANALYZER. THE SERVICE HISTORY REVIEW FOUND THAT THE FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO INSPECT THIS ARCHITECT C800401 FOR THIS ISSUE. THE FIELD SERVICE REPRESENTATIVE PERFORMED PREVENTATIVE MAINTENANCE (PM). NO FURTHER COMPLAINTS FOR THIS INSTRUMENT AND THIS ISSUE WERE FOUND. THE ABBOTT ARCHITECT SYSTEM OPERATIONS MANUAL (B)(4) (B)(6) 2008 PROVIDES THE FOLLOWING INFORMATION RELATED TO THE CUSTOMERS OBSERVATIONS: SECTION 7 OPERATIONAL PRECAUTIONS AND LIMITATIONS, UNDER LIMITATIONS OF RESULT INTERPRETATION: ASSAY RESULTS MUST BE USED WITH OTHER CLINICAL DATA, FOR EXAMPLE, SYMPTOMS, OTHER TEST RESULTS, PATIENT HISTORY, CLINICAL IMPRESSIONS, INFORMATION AVAILABLE FROM CLINICAL EVALUATION, AND OTHER DIAGNOSTIC PROCEDURES. ALL DATA MUST BE CONSIDERED FOR PATIENT CARE MANAGEMENT. IF ASSAY RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. THE ARCHITECT SYSTEM HAS BEEN VALIDATED FOR ITS INTENDED USE. HOWEVER, ERRORS CAN OCCUR DUE TO POTENTIAL OPERATOR ERRORS AND ARCHITECT SYSTEM TECHNOLOGY LIMITATIONS. SECTION 10 TROUBLESHOOTING AND DIAGNOSTICS, OBSERVED PROBLEMS PROVIDES UNDER THE SECTIONS INDICATED BELOW MULTIPLE PROBABLE CAUSES AND RESOLUTIONS RELATED TO THE CUSTOMERS OBSERVATION: DEPRESSED CONCENTRATION - PHOTOMETRIC RESULTS SINGLE ASSAY (C SYSTEM). ERRATIC RESULTS, POOR PRECISION - PHOTOMETRIC RESULTS (C SYSTEM). BASED ON THE INVESTIGATION, IT WAS DETERMINED THAT CLINICAL CHEMISTRY IRON REAGENT (B)(4) LOT NUMBER 62037HW00 IS PERFORMING AS EXPECTED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. THIS IS THE FINAL REPORT.

Description of Event or Problem

THE ACCOUNT STATED THAT THE ARCHITECT IRON REAGENT HAS GENERATED LOW RESULTS ON 2 PATIENT SAMPLES. PATIENT # 1 WAS RETESTED ON THE OLYMPUS AND PATIENT #2 WAS RETESTED ON BAYER ANALYZER. FOR PATIENT #1, THE ARCHITECT IRON RESULT = 8 UG/DL AND REPEATED AT 8 UG/DL (WHICH INDICATES AN IRON DEFICIENCY). THE SAMPLE WAS TESTED ON THE OLYMPUS ANALYZER AND THE RESULT = 62 (WHICH INDICATES A NORMAL RESULT). THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

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