CLINICAL CHEMISTRY LACTATE DEHYDROGENASE

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 FOR THIS PRODUCT. THE ARCHITECT CLINICAL CHEMISTRY LACTATE DEHYDROGENASE REAGENT ASSAY INSERT AND THE ARCHITECT OPERATIONS MANUAL CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. AS THE REAGENT LOT HAS EXPIRED, NO TESTING WAS PERFORMED. BASED ON THE INFORMATION OBTAINED THROUGH THIS EVALUATION AND THE INFORMATION FROM THE CUSTOMER SITE, THERE IS EVIDENCE TO REASONABLY SUGGEST THAT A PRODUCT MALFUNCTION OCCURRED. HOWEVER, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED. LOT/SERIAL NUMBER WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE; THEREFORE, ONLY A DI IS PROVIDED.

Description of Event or Problem

THE CUSTOMER REPORTS FALSELY ELEVATED CLIN CHEM LDH ASSAY RESULTS BEING GENERATED ON PATIENT SAMPLES TESTED ON THE ARCHITECT C8000 ANALYZER. CONTROLS TREND HIGH BUT STILL WITHIN SPECIFICATIONS. PROFICIENCY SAMPLES HAVE ALWAYS PASSED. THE CUSTOMER USES SERUM PATIENT SAMPLES AND ALWAYS RUNS SAMPLES IN A 1:3 DILUTION. THE CUSTOMER NOTES THAT WHEN THE SAMPLES ARE RETESTED THE FOLLOWING DAY, VALUES DROP SIGNIFICANTLY INTO THE NORMAL REFERENCE RANGE (12% TO 47% DECREASE). WHEN USING REAGENT LOT 11911UN15, THE CUSTOMER REPORTED THE FOLLOWING VALUES (DAY 1, DAY 2): SAMPLE 1: 277, 243 U/L; SAMPLE 2: 336, 189 U/L; SAMPLE 3: 679, 536 U/L; SAMPLE 4: 171, 149 U/L; AND SAMPLE 5: 200, 176 U/L. THESE SAME TYPES OF RANGES WERE SEEN ON A SECOND ARCHITECT CSYSTEM IN THE LAB. THE CUSTOMER USES A NORMAL REFERENCE RANGE OF 125 - 220 U/L. SOME RESULTS HAVE BEEN QUESTIONED BY PHYSICIANS AS BEING HIGHER THAN EXPECTED. THERE IS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.