LDL_C LDL-CHOLESTEROL PLUS 3ND GENERATION

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). QUALITY CONTROL WAS ACCEPTABLE ON THE DATE OF PATIENT TESTING. THE INVESTIGATION DETERMINED THAT 'DENGUE SHOCK' IS VERY SIMILAR TO THE STATUS OF SEPSIS OR AFTER A STROKE OR MYOCARDIAL INFARCTION. UNDER THESE CONDITIONS THE LIPOPROTEIN PATTERN IS TOTALLY DISTURBED. IT CANNOT BE EXPECTED THAT NORMAL LDL PARTICLES WILL BE PRESENT IN THE PATIENT SAMPLE. AS A CONSEQUENCE ROCHE DIRECT TESTS FOR LDL-C MAY REPORT LOW RESULTS. THE PATIENT SAMPLE WAS NOT AVAILABLE FOR FURTHER TESTING.

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED LOW LDL_C LDL-CHOLESTEROL PLUS 2ND GENERATION RESULTS ON A COBAS 6000 C (501) MODULE. THE COBAS 6000 C (501) MODULE SERIAL NUMBER USED FOR PATIENT TESTING WAS (B)(4). THE CUSTOMER PROVIDED QUESTIONED RESULTS FOR ONE PATIENT. ON (B)(6) 2020, THE INITIAL LDL RESULT WAS 27.4 MG/DL. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY AND QUESTIONED BY THE CLINICIAN. THE CUSTOMER PERFORMED REPEAT TESTING AND THE LDL RESULT WAS 22.6 MG/DL. THE PATIENT'S SERUM WAS TESTED AT A DIFFERENT LABORATORY USING ANOTHER ANALYZER, ARCHITECT, AND THE LDL RESULT WAS 177 MG/DL. ON (B)(6) 2020, THE PATIENT'S SERUM WAS TESTED ON A ROCHE ANALYZER AT A REFERENCE LAB AND THE LDL RESULT WAS 28.8 MG/DL.