CLINICAL CHEMISTRY LACTATE DEHYDROGENASE

Additional Manufacturer Narrative

AN ABBOTT FIELD TECHNICIAN VISITED THE CUSTOMER SITE TO REVIEW THE ISSUE WITH THE CUSTOMER. THE REAGENT WAS REPLACED AND PLACED IN A DIFFERENT POSITION ON THE ANALYZER. THE WATER QUALITY WAS CHECKED AND FOUND TO BE ACCEPTABLE. THE SAMPLE DILUENT WAS ALSO REPLACED AND THE CUSTOMER INFORMED TO REPLACE DAILY. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE. INSTRUMENT LOGS AND HISTORY FILES WERE REVIEWED AS STORED IN THE ARCHITECT C16000 ANALYZER FOR THE CLIN CHEM LDH ASSAY. THE ASSAY CURVE PATTERN WAS UNREMARKABLE AND SIMILAR TO OTHER CURVES. FROM (B)(6) 2017, SIXTY INSTANCES OF ASPIRATION ERROR CODES WERE LOGGED ALONG WITH TWENTY-FOUR INSTANCES OF INCOMPLETE CUVETTE WASHING ERROR CODES. SAMPLE HANDLING AND/OR SAMPLE INTEGRITY ISSUES CANNOT BE RULED OUT AS POSSIBLE CAUSES OF THE CUSTOMER ISSUE AS WELL AS INCOMPLETE INSTRUMENT MAINTENANCE. THE ARCHITECT CLINICAL CHEMISTRY LDH ASSAY PACKAGE INSERT AND THE ARCHITECT OPERATIONS MANUAL CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A SYSTEMIC ISSUE OR PRODUCT DEFICIENCY EXISTS.

Description of Event or Problem

ON (B)(6) 2017, THE FOLLOWING ARCHITECT CLIN CHEM ASSAY RESULTS WERE GENERATED ON AN ARCHITECT C16000 ANALYZER: (B)(6): INITIAL RESULT OF 237 U/L THAT RETESTED AT 191 U/L. (B)(6): INITIAL RESULT OF 279 U/L THAT RETESTED AT 207 U/L. THE CUSTOMER USES A NORMAL REFERENCE RANGE OF 125 TO 220 U/L. THE CUSTOMER WILL BEGIN TESTING ALL SAMPLES FOR LDH IN DUPLICATE. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT CARE REPORTED. A SERVICE CALL WAS INITIATED.