LDLC3 LDL-CHOLESTEROL GEN.3

Additional Manufacturer Narrative

A SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE CONSISTENT WITH A LIPID DISORDER RESULTING IN NON ESTERIFIED CHOLESTEROL LEADING TO A LIPOPROTEIN DENSITY SHIFT AND WITH TRIGLYCERIDES ENRICHED LIPOPROTEIN. LDL PARTICLES WITH INCREASED TRIGLYCERIDES CONTENT AND FREE CHOLESTEROL ARE NOT REGARDED AS NORMAL LDL PARTICLES. THE ROCHE LDLC3 ASSAY DOES NOT RECOGNIZE THESE PARTICLES, BUT THE ABBOTT ASSAY DID. SINCE LDL PARTICLES WITH INCREASED TRIGLYCERIDES CONTENT AND FREE CHOLESTEROL ARE NOT REGARDED AS NORMAL LDL PARTICLES, THE PRODUCT MEETS SPECIFICATIONS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE INVESTIGATION IS CURRENTLY ONGOING. THE EVENT OCCURRED IN: (B)(6).

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE LDL_C LDL-CHOLESTEROL PLUS 3RD GENERATION RESULT FOR 1 PATIENT SAMPLE TESTED ON A COBAS 8000 C702 MODULE COMPARED TO THE RESULTS FROM ABBOTT AND LIPOPROTEIN ELECTROPHORESIS. THE LDL_C RESULT FROM THE COBAS C702 WAS 29.2 MG/DL. THE ABBOTT RESULT WAS 179 MG/DL. BASED ON THE LIPOPROTEIN ELECTROPHORESIS RESULTS OF BETA 52.7 PERCENT THE CALCULATED LDL RESULT WOULD BE 169.06 MG/DL (52.7 * 320.79). THE LDL_C RESULT OF 29.2 MG/DL WAS REPORTED OUTSIDE OF THE LABORATORY. BASED ON THE ABBOTT AND LIPOPROTEIN ELECTROPHORESIS RESULTS A CORRECTED REPORT WAS ISSUED. A NEW SAMPLE FROM THE SAME PATIENT TESTED ON AN UNSPECIFIED DATE HAD AN LDL RESULT OF 270 MG/DL. THE COBAS C702 SERIAL NUMBER WAS (B)(4).