TOSOH HLC-723G8 ANALYZER G8

Additional Manufacturer Narrative

CORRECTION: B3

Additional Manufacturer Narrative

CORRECTION: H10, "THE ST AIA-PACK HEMOGLOBIN A1C (HBA1C) ANALYTE APPLICATION MANUAL STATES THE FOLLOWING" AND DESCRIPTION IS CORRECTED TO THE FOLLOWING: THE G8 VARIANT ANALYSIS MODE OPERATOR'S MANUAL STATES THE FOLLOWING: 7.1 DATA MANAGEMENT DETAILS. SCREEN 7-5 ASSAY MODE SELECTION SCREEN: CHECK THAT VARIANT MODE IS SELECTED AND THEN PRESS THE SET KEY.

Additional Manufacturer Narrative

IT WAS CONCLUDED THAT AT SOME POINT THE ANALYZER BECAME MIS-CONFIGURED FROM THE CORRECT VARIANT MODE TO STD (STANDARD) MODE WHICH WAS CAUSING INCORRECT REPORTED RESULTS, BUT THERE WAS ONLY ONE PATIENT SAMPLE THAT INCLUDED VARIANTS THAT WERE PRESENT WHICH EXPLAINS WHY THE QUALITY CONTROL MATERIAL ALWAYS RECOVERED CORRECTLY. THE ANALYZER IS FUNCTIONING AS EXPECTED. A 13-MONTH COMPLAINT HISTORY REVIEW AND SERVICE HISTORY REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4) FROM 14DEC2018 THROUGH AWARE DATE (B)(6) 2020. THERE WERE NO OTHER SIMILAR COMPLAINTS IDENTIFIED DURING THE REVIEW PERIOD. THE ST AIA-PACK HEMOGLOBIN A1C (HBA1C)ANALYTE APPLICATION MANUAL STATES THE FOLLOWING: 5) SPECIMEN PROCESSING, 5A) PREPARATION, FOLLOWING SPECIFIC INSTRUCTIONS IN THE OPERATOR'S MANUAL FOR YOUR ANALYZER, PLACE PRETREATED SAMPLES ON THE INSTRUMENT APPROPRIATELY. FOR FURTHER INFORMATION REGARDING SAMPLE PREPARATION AND INSTRUMENT OPERATION, REFER TO THE SPECIMEN COLLECTION AND HANDLING SECTION AND CONSULT THE SPECIFIC TOSOH AIA SYSTEM OPERATOR'S MANUAL. EVALUATION OF RESULTS QUALITY CONTROL IN ORDER TO MONITOR AND EVALUATE THE PRECISION OF THE ANALYTICAL PERFORMANCE, IT IS RECOMMENDED THAT AIA-PACK HBA1C CONTROL SET BE ASSAYED DAILY. THE MINIMUM RECOMMENDATIONS FOR THE FREQUENCY OF RUNNING CONTROL MATERIAL ARE: AFTER CALIBRATION, CONTROLS ARE RUN IN ORDER TO CONFIRM THE CALIBRATION CURVE. CONTROLS SHOULD BE RUN IF CERTAIN SERVICE PROCEDURES ARE PERFORMED (E.G. TEMPERATURE ADJUSTMENT, SAMPLING MECHANISM CHANGES, MAINTENANCE OF THE WASH PROBE OR DETECTOR LAMP ADJUSTMENT OR CHANGE). AFTER DAILY MAINTENANCE, CONTROLS SHOULD BE RUN IN ORDER TO VERIFY THE OVERALL PERFORMANCE OF THE TOSOH AIA SYSTEM ANALYZER. IF ONE OR MORE CONTROL SAMPLE VALUE(S) IS OUT OF THE ACCEPTABLE RANGE, IT WILL BE NECESSARY TO INVESTIGATE THE VALIDITY OF THE CALIBRATION CURVE BEFORE REPORTING PATIENT RESULTS. STANDARD LABORATORY PROCEDURES SHOULD BE FOLLOWED IN ACCORDANCE WITH THE REGULATORY AGENCY UNDER WHICH THE LABORATORY OPERATES. LIMITATIONS OF THE PROCEDURE: FOR DIAGNOSTIC PURPOSES, THE RESULTS OBTAINED FROM THIS ASSAY SHOULD BE USED IN CONJUNCTION WITH OTHER DATA (E.G., SYMPTOMS, RESULTS OF OTHER TESTS, CLINICAL IMPRESSIONS, THERAPY, ETC.). USING ST AIA-PACK HBA1C, THE HIGHEST CONCENTRATION OF HBA1C MEASURABLE IS 14.0%, AND THE LOWEST MEASURABLE CONCENTRATION IS 3.0%. IN THE CASE OF SEVERE ANEMIA SPECIMENS HAVING LESS THAN 7.0 G/DL TOTAL HEMOGLOBIN CONCENTRATION, ST AIA-PACK HBA1C MAY GIVE LOWER RESULT. SUCH SEVERE ANEMIA SPECIMEN SHOULD BE ASSAYED BY A DIFFERENT ASSAY PRINCIPLE. ALL RESULTS SHOULD BE INTERPRETED WITH RESPECT TO THE CLINICAL PICTURE OF THE PATIENT. LIPEMIA HAS AN INSIGNIFICANT EFFECT ON THE ASSAY EXCEPT IN THE CASE OF GROSS LIPEMIA WHERE SPATIAL INTERFERENCE MAY OCCUR. SAMPLES CONTAINING FIBRIN MAY EXHIBIT EITHER FALSELY ELEVATED OR FALSELY DECREASED RESULTS. FIBRIN MUST BE ELIMINATED FROM THE SAMPLE BEFORE ASSAY BEGINS. SAMPLES FROM PATIENTS TAKING MEDICINES AND / OR MEDICAL TREATMENT MAY SHOW ERRONEOUS RESULTS. SAMPLES FROM PATIENTS WHO HAVE RECEIVED PREPARATIONS OF SHEEP POLYCLONAL ANTIBODIES FOR DIAGNOSIS OR THERAPY MAY CONTAIN HUMAN ANTI-SHEEP ANTIBODY. SUCH SAMPLES MAY SHOW FALSELY ELEVATED VALUES WHEN TESTED FOR ST AIA-PACK HBA1C. FOR A MORE COMPLETE UNDERSTANDING OF THE LIMITATIONS OF THIS PROCEDURE, PLEASE REFER TO THE SPECIMEN COLLECTION AND HANDLING, WARNINGS AND PRECAUTIONS, STORAGE & STABILITY AND PROCEDURAL NOTES SECTIONS IN THIS INSERT SHEET. SAMPLES FROM PATIENTS WHO HAD AN INJECTION OF FLUORESCEIN, WHICH IS USED IN FLUORESCEIN FUNDUS ANGIOGRAPHY, MAY CAUSE FALSELY ELEVATED RESULTS. EXPECTED VALUES: THE AMERICAN DIABETES ASSOCIATION (ADA) EXPECTED VALUES RANGE IS 4.0 TO 6.0 %* FOR PEOPLE WITHOUT DIABETES (12-15). *: HBA1C (NGSP %). THE PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO THE ANALYZER SETTING BEING INCORRECTLY SET TO STD ANALYSIS MODE INSTEAD OF VARIANT ANALYSIS MODE. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

Description of Event or Problem

A CUSTOMER REPORTED RECEIVING INCORRECT SA1C RESULTS ON THE ANALYZER. THE RESULTS WERE REPORTED TO A PHYSICIAN AND THE PHYSICIAN COMPLAINED. THE CUSTOMER ALSO STATED THAT THEY HAVE REPORTED POSSIBLY 3 OR 4 PREVIOUS RESULTS THAT WERE QUESTIONED BY THE PHYSICIAN RECENTLY IN THE LAST 2 TO 3 MONTHS. THE CUSTOMER HAS NO PAPER TRAIL OR DOCUMENTATION AVAILABLE ON THE PREVIOUS COMPLAINT RESULTS OTHER THAN THE CURRENT ONE REPORTED TO TS (TECHNICAL SUPPORT). THE CUSTOMER STATED THAT ALL OF THE SUSPECTED INCORRECTLY REPORTED PATIENT RESULTS WERE FROM AFRICAN AMERICAN MALES. THERE WERE NO SC OR SS TRAITS PRESENT ON THE C-GRAMS AS THE CUSTOMER COULD RE-CALL, AND THE CURRENT REPORTED PATIENT RESULT ALSO DOES NOT HAVE ANY HV PEAKS PRESENT. THE PHYSICIAN QUESTIONED THE PATIENT RESULT BECAUSE THEY WERE INCONSISTENT WITH THE PATIENTS PREVIOUS A1C HISTORY. THE PATIENT SAMPLE WAS SENT OUT TO A HOSPITAL LAB AND THE LABS RESULT RETURNED WERE INCONSISTENT WITH THE RESULTS FROM THE ANALYZER. THE CUSTOMER RUNS BIO-RAD LOT 38590 AS QUALITY CONTROL (QC) MATERIAL. THIS COLUMN WAS INSTALLED LAST WEEK, AND THE RESULTS REPORTED HAVE OCCURRED WITH THIS CURRENT COLUMN AND PREVIOUS COLUMNS. THE CUSTOMER ALSO REPORTED THAT THE PREVIOUS UNDOCUMENTED QUESTIONED RESULTS WERE REPORTED LOWER THAN EXPECTED, BUT THE QC WAS ALWAYS REPORTING WITHIN NORMAL RANGES FOR BOTH QC LEVELS. TECHNICAL SUPPORT FOUND THAT THE CUSTOMERS ANALYZER WAS IN STD ANALYSIS MODE INSTEAD OF THE CORRECT VAR ANALYSIS MODE. THE ANALYZER WAS SET FOR REPORTING IN BOTH IFCC AND NSGP MODE. WHEN THIS WAS BROUGHT TO THE ATTENTION OF THE CUSTOMER THE TS WAS TOLD THAT THEY MAY HAVE HAD A RECENT POWER ISSUE IN THE LAB THAT CAUSED AN ANALYZER SHUTDOWN AND LOSS OF PARAMETERS. THE TS ASSISTED THE CUSTOMER WITH SETTING THE CORRECT ANALYZER MODE FOR ANALYSIS OF VARIANT AND CORRECTED THE REPORTING RESULT MODE TO NGSP ONLY. THE SA1CRT HAD WAS SET TO THE CORRECT VARIANT MODE THEN THE FLOW FACTOR RESET ITSELF BACK THE CORRECT PARAMETERS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT REPORTING OF RESULTS.