LACTATE DEHYDROGENASE

Additional Manufacturer Narrative

FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, INSTRUMENT LOG REVIEW, AND A REVIEW OF LABELING. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS RELATED TO THE COMPLAINT ISSUE. INSTRUMENT LOGS AND HISTORY FILES THAT WERE STORED ON THE CUSTOMER'S ARCHITECT C8000 ANALYZER WERE REVIEWED. THE ASSAY CURVE PATTERN FOR THE QUESTIONED SAMPLE ID WAS UNREMARKABLE AND SIMILAR TO OTHER CURVES. REVIEW OF THE INSTRUMENT HISTORY LOG FROM (B)(6) 2017 TO (B)(6) 2017 FOUND 543 INSTANCES OF ASPIRATION ERROR CODES AND SEVENTY-FIVE 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. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE AVAILABLE INFORMATION AND THIS EVALUATION, NO SYSTEMIC ISSUE AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE ELEVATED ARCHITECT LACTATE DEHYDROGENASE RESULT FROM ONE PATIENT. SAMPLE (B)(6) GENERATED AN INITIAL RESULT OF 419 U/L AND RETEST RESULT OF 199 U/L. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.