LDL_C LDL-CHOLESTEROL PLUS 3ND GENERATION

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

SINCE (B)(6) 2015, THE CUSTOMER RECEIVED QUESTIONABLE HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION AND LDL_C LDL-CHOLESTEROL PLUS 2ND GENERATION RESULTS WHEN COMPARED TO THE RESULTS RECEIVED FOR CHOL2 CHOLESTEROL GEN.2. THE SUM OF THE HDL AND LDL RESULTS DID NOT FIT TO THE CHOLESTEROL RESULT. IN SOME CASES, THE RESULTS DID NOT FIT TO THE DISEASE OF THE PATIENT. DATA WAS PROVIDED FROM TWO COBAS C501 ANALYZERS. THE SERIAL NUMBER FOR ONE ANALYZER WAS (B)(4). THE SERIAL NUMBER OF THE OTHER ANALYZER WAS REQUESTED, BUT WAS NOT PROVIDED. THIS MEDWATCH IS FOR THE LDL ASSAY. REFER TO THE MEDWATCH WITH (B)(6) FOR THE HDL ASSAY. THE SPECIFIC NUMBER OF PATIENT SAMPLES INVOLVED WAS UNKNOWN. DATA WAS PROVIDED FOR 65 PATIENT SAMPLES. REFER TO THE ATTACHMENTS TO THE MEDWATCH FOR ALL PATIENT DATA. THE CUSTOMER BELIEVED THE RESULTS FOR CHOLESTEROL TO BE CORRECT AND THE RESULTS FOR HDL AND LDL TO BE INCORRECT. INFORMATION CONCERNING IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED, BUT IT WAS UNKNOWN. THERE WAS NO ADVERSE EVENT. UPON REVIEW OF THE PATIENT DATA, IT WAS ASSUMED THE ROOT CAUSE WAS ABNORMAL LIVER FUNCTION OF THE PATIENTS AS MANY LOW HDL RESULTS AND LOW LDL/CHOL RESULTS WERE NOTED WITH OTHER LIVER PARAMETERS OUT OF THE NORMAL RANGE. BASED ON THE PROVIDED ANALYZER DATA, THE SYSTEM PERFORMANCE OF BOTH C501 ANALYZERS WAS ACCEPTABLE. THEREFORE A GENERAL ISSUE WITH SYSTEMS WAS EXCLUDED.