LDLC3

Additional Manufacturer Narrative

MEDWATCH INITIAL REPORTER NAME AND ADDRESS: (B)(6).

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH LDL_C LDL-CHOLESTEROL PLUS 3RD GENERATION ON A COBAS 8000 C 702 MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS INITIALLY TESTED ON THE C 702 ANALYZER, RESULTING IN AN LDL VALUE OF 3.5 MMOL/L. THE SAMPLE WAS REPEATED ON A HITACHI 7600 COMPETITOR SYSTEM, RESULTING IN AN LDL VALUE OF 17.38 MMOL/L. THE SERIAL NUMBER OF THE C 702 ANALYZER WAS REQUESTED, BUT NOT PROVIDED.

Additional Manufacturer Narrative

THE PATIENT HAS ALAGILLE SYNDROME WHICH INVOLVES LIVER DISEASE (CHOLESTASIS). SINCE THE LIVER IS IMPAIRED IN THE DISEASE STATE OF CHOLESTASIS, THE MEASUREMENT OF HDL AND LDL IS OF NO MEDICAL VALUE. THE VALUES MEASURED FOR LDL MAY BE INTERFERED WITH BY BILIRUBIN BECAUSE THE CHOLESTASIS GOES ALONG WITH ELEVATED LEVELS OF BILIRUBIN DEPENDING ON THE DISEASE STAGE. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM.