CLINICAL CHEMISTRY PHOSPHORUS

Additional Manufacturer Narrative

A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE OR NON-STATISTICAL TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. NO NON-CONFORMANCES WERE IDENTIFIED ASSOCIATED WITH THE CUSTOMER OBSERVATIONS. THERE WERE NO RETURNS MADE AVAILABLE FROM THE CUSTOMER SITE. A REVIEW OF THE ARCHITECT C8000 ANALYZER INSTRUMENT LOGS WAS PERFORMED AND ONLY THE MORNING AND REPEAT SAMPLE RESULTS COULD BE FOUND. THERE WERE HOWEVER, 28 OCCURRENCES OF ERROR CODE 3375 (UNABLE TO PROCESS TEST, ASPIRATION ERROR OCCURRED) (B)(6) 2017. FREQUENT OCCURRENCES OF THIS ERROR CODE OR OCCURRENCES WITH NO ASSIGNABLE CAUSE MAY INDICATE INADEQUATE CENTRIFUGATION OR SAMPLE PREPARATION. THE ARCHITECT CLIN CHEM PHOSPHORUS ASSAY PACKAGE INSERT AND THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDE INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE RESULTS OF THIS EVALUATION AND THE INFORMATION FROM THE CUSTOMER SITE, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED. USE ERROR MAY HAVE CONTRIBUTED TO THE CUSTOMER'S ISSUE AS ERROR CODES INDICATE PRE-ANALYTICAL SAMPLE HANDLING MAY HAVE CONTRIBUTED TO THIS ISSUE. (B)(6).

Description of Event or Problem

THE CUSTOMER REPORTS THAT ONE PATIENT (BEING TREATED FOR HYPERCALCEMIA AND RECEIVING CALCITONIN / HEMOFILTERED / 24 HOURS) SAMPLE GENERATED THE FOLLOWING CLIN CHEM PHOSPHORUS ASSAY RESULTS ON AN ARCHITECT C8000 ANALYZER: (B)(6): 3.87, 2.76, 3.27 AND 2.52 MMOL/L. THE SAMPLE WAS DRAWN WITH A HEPARIN COLLECTION TUBE. AN ADDITIONAL SAMPLE WAS DRAWN ON THIS PATIENT LATER IN THE DAY ((B)(6)) AND GENERATED RESULTS IN THE RANGE OF 1.35-1.83 MMOL/L (N=13) ALSO DRAWN IN A HEPARIN COLLECTION TUBE. THE CUSTOMER THEN RAN A SAMPLE FROM THIS SAME PATIENT THAT WAS DRAWN IN A RED TOP COLLECTION TUBE ((B)(6)). THIS SAMPLE GENERATED RESULTS IN THE RANGE OF 0.98-1.27 MMOL/L (N=10). THE CUSTOMER USES A NORMAL REFERENCE RANGE OF 0.74-1.52 MMOL/L. THE PATIENT IS IN RECOVERY. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.