LDL_C LDL-CHOLESTEROL PLUS 3ND GENERATION

Additional Manufacturer Narrative

SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION AND WAS TESTED ON A COBAS 6000 C (501) MODULE AND A BECKMANN COULTER AU 5800. THE CUSTOMER'S LDL AND HDL RESULTS WERE CONFIRMED. FURTHER TESTING BY SEPARATION OF LIPID FRACTION SHOWED A VERY ABNORMAL LIPOPROTEIN PATTERN WITH A BROAD LDL BAND CONSISTING OF TRIGLYCERIDE ENRICHED PARTICLES. THE ABNORMAL LIPID COMPOSITION OF THE LIPOPROTEIN FRACTIONS LED TO A CHANGE OF THE DENSITY, WHICH WERE ONLY PARTLY OR NOT DETECTED AT ALL BY THE ROCHE LDL TEST. BASED ON THESE RESULTS IT WAS DETERMINED THE ABNORMAL LIPOPROTEIN PATTERN LEAD TO NON-SPECIFIC REACTIONS. SINCE THE ASSAY CORRECTLY DETECTED THE CORRECT PARTICLES IN THE SAMPLE, A GENERAL REAGENT ISSUE WAS NOT FOUND.

Additional Manufacturer Narrative

(B)(4). (B)(6).

Description of Event or Problem

THE CUSTOMER RECEIVED QUESTIONABLE LDL_C LDL-CHOLESTEROL PLUS 3RD GENERATION AND HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION RESULTS FOR ONE PATIENT. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE HDL ASSAY. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THE DOCTOR QUESTIONED WHY THE LDL RESULTS WERE DIFFERENT BETWEEN THE DIFFERENT METHODS. THE CUSTOMER WAS PREVIOUSLY USING BECKMAN COULTER AU AND ON (B)(6) 2017 THE LDL RESULT FOR THE PATIENT WAS 10.13 MMOL/L. ON (B)(6) 2017, THIS SAMPLE WAS SENT TO A REFERENCE LAB FOR A LIPOPROTEIN METABOLISM PROFILE USING ELECTROPHORESIS, ULTRACENTRIFUGATION, AND AUTOMATED ENZYMATIC BETA QUANTITATION. THE RESULT WAS 19 MMOL/L. ON (B)(6) 2017, THE CUSTOMER BEGAN USING THE ROCHE LDL-C GEN. 3 ASSAY. ON (B)(6) 2017, THE SAME PATIENT WAS TESTED AND THE RESULT WAS 2.69 MMOL/L. THE SAMPLE WAS REPEATED WITH A RESULT OF 2.703 MMOL/L. THE SAMPLE WAS THEN REPEATED ON A BECKMAN AU ANALYZER AT A DIFFERENT SITE AND THE RESULT WAS > 10.3 MMOL/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER USED A COBAS 8000 C 502 MODULE. THE SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED.