LDLC3

Additional Manufacturer Narrative

THE PROVIDED DATA INDICATED THAT THE LDLC3 VALUE REFLECTED MORE CLOSELY THE TRUE LDL VALUE IN THE PATIENT SAMPLE. THE PRODUCT LABELING STATES: "ABNORMAL LIVER FUNCTION AFFECTS LIPID METABOLISM; CONSEQUENTLY HDL AND LDL RESULTS ARE OF LIMITED DIAGNOSTIC VALUE. IN SOME PATIENTS WITH ABNORMAL LIVER FUNCTION, THE LDL-CHOLESTEROL RESULT IS SIGNIFICANTLY NEGATIVELY BIASED VERSUS BETA QUANTIFICATION RESULT." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS CONSISTENT WITH AN INTERFERENCE.

Additional Manufacturer Narrative

THE C702 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH LDL-CHOLESTEROL GEN.3 (LDLC3) ASSAY ON A COBAS 8000 C702 MODULE. INITIAL RESULT: 2.32 MMOL/L. THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND THE SAMPLE WAS THEN REPEATED. REPEAT RESULT: 6.03 MMOL/L (TESTED ON HITACHI WAKO). THE REPEAT RESULT WAS CONSISTENT WITH THE LDL CALCULATION METHOD (FRIEDEWALD). THE CUSTOMER SUSPECTED AN INTERFERENCE OF LIPOPROTEIN X OR LP(X).