CLINICAL CHEMISTRY PHOSPHORUS

Additional Manufacturer Narrative

A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO RELATED ADVERSE OR NON-STATISTICAL TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. NO NON-CONFORMANCES OR DEVIATIONS WERE IDENTIFIED. NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE. NO TESTING WAS PERFORMED. A REVIEW OF THE ARCHITECT C16000 ANALYZER INSTRUMENT LOGS WAS PERFORMED. THE HISTORY LOG SHOWS NUMEROUS (61) OCCURRENCES OF ERROR CODE (EC) 3375 (ASPIRATION ERROR) FROM (B)(6) 2017. THE MAINTENANCE LOG FROM (B)(6) SHOWS THE CUSTOMER ONLY PERFORMED AS NEEDED MAINTENANCE (6052) ON FEBRUARY 2ND. THE CUSTOMER DISCONTINUED THE AS NEEDED MAINTENANCE (6052) CUVETTE WASH PROCEDURE ON (B)(6) 2017, PRIOR TO THE DISCREPANT RESULT ON (B)(6) 2017. THE ARCHITECT CLINICAL CHEMISTRY PHOSPHORUS ASSAY PACKAGE INSERT AND THE ARCHITECT SYSTEM OPERATIONS MANUAL CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE AVAILABLE INFORMATION FROM THE CUSTOMER SITE AND FROM THE RESULTS OF THIS EVALUATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST A PRODUCT MALFUNCTION OCCURRED. SERUM AND PLASMA SAMPLES, IF NOT SPUN ACCORDING TO MANUFACTURER'S SPECIFICATIONS, MAY GENERATE INACCURATE VALUES. IT IS CRITICAL THAT SPIN TIMES ARE NOT REDUCED AS COMPENSATION FOR HIGHER CENTRIFUGE SPEEDS. THE DEVICE MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE. THE CUSTOMER REPORTS INSPECTING THE SAMPLE AND FINDING A HIGH AMOUNT OF FLOATING FIBRIN IN THE PATIENT SERUM SAMPLE. NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. PATIENT IDENTIFIER: (B)(6) UDI: (B)(4) LOT/SERIAL NUMBER WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE; THEREFORE, ONLY A DI IS PROVIDED.

Description of Event or Problem

THE CUSTOMER REPORTS THAT ONE PATIENT SAMPLE (SID (B)(6)) GENERATED AN INITIAL ELEVATED ARCHITECT CLIN CHEM PHOSPHORUS ASSAY RESULT OF 3.67 MMOL/L (11.36 MG/DL). PREVIOUSLY, THIS PATIENT HAD GENERATED A RESULT OF 0.92 MMOL/L (2.8 MG/DL). THE SAMPLE WAS THEN RETESTED WITH A VALUE OF 0.98 MMOL/L (3.0 MG/DL). THE SAMPLE WAS THEN TESTED ON ANOTHER ARCHITECT SYSTEM IN THE LAB AND GENERATED A RESULT OF 1.00 MMOL/L (3.1 MG/DL). NO SUSPECT RESULTS HAD BEEN REPORTED FROM THE LAB. A PRECISION RUN WAS PERFORMED AND MET SPECIFICATIONS. THE SAMPLE WAS INSPECTED AND DID CONTAIN A "HIGH AMOUNT OF FLOATING FIBRIN." THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.