LDL_C LDL-CHOLESTEROL PLUS 2ND GENERATION

Additional Manufacturer Narrative

(B)(6).

Description of Event or Problem

THE CUSTOMER RECEIVED A QUESTIONABLE LOW LDL_C LDL-CHOLESTEROL PLUS 2ND GENERATION RESULT FOR ONE LIPEMIC PATIENT SAMPLE FROM THE COBAS 6000 C 501 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 62 MG/DL AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE CLINICIAN REJECTED THE RESULT AND THE SAMPLE WAS REPEATED. ON THE SAME ANALYZER, THE REPEAT RESULT WAS 64 MG/DL. ON A BECKMAN COULTER ANALYZER WITH A RESULT OF 189 MG/DL. ON (B)(6) 2018, THE REPEAT RESULTS WERE 57 MG/DL AND 58 MG/DL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. A GENERAL REAGENT PROBLEM COULD BE RULED OUT AS CALIBRATION AND QC WERE ACCEPTABLE.

Additional Manufacturer Narrative

SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION. THE RESULT WITH THE BECKMAN METHOD COULD NOT BE CONFIRMED BY TWO INDEPENDENT METHODS. THE CUSTOMER'S RESULT FROM THE COBAS 6000 C 501 WAS FOUND TO BE CORRECT AS IT MATCHED THE RESULTS FROM LIPID AGAROSE GEL ELECTROPHORESIS AND THE LIPOPRINT METHOD.