LDLC3

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE LDLC3- (LOW DENSITY, LIPOPROTEIN) RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. PATIENT 1: THE INITIAL RESULT WAS 26 MG/DL. THE SAME SAMPLE WAS REPEATED ON ANOTHER PRO ANALYZER WITH A RESULT OF 27 MG/DL AND ON A C311 ANALYZER WITH A RESULT OF 22 MG/DL. THE SAME SAMPLE WAS REPEATED ON AN ABBOTT ANALYZER AND THE RESULT WAS 87 MG/DL. PATIENT 2: ((B)(6) 2024): THE INITIAL RESULT WAS 10 MG/DL. THE SAME SAMPLE WAS REPEATED ON ANOTHER PRO ANALYZER WITH A RESULT OF 11 MG/DL. THE SAME SAMPLE WAS REPEATED ON AN ABBOTT ANALYZER AND THE RESULT WAS 119 MG/DL.

Additional Manufacturer Narrative

THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION FOUND N-ACETLY CYSTEINE INJECTIONS WERE ADMINISTERED. THIS INTERFERENCE IS DOCUMENTED IN PRODUCT LABELING FOR THE ASSAY "ACETAMINOPHEN INTOXICATIONS ARE FREQUENTLY TREATED WITH N-ACETYLCYSTEINE. N-ACETYLCYSTEINE AT THE THERAPEUTIC CONCENTRATION WHEN USED AS AN ANTIDOTE AND THE ACETAMINOPHEN METABOLITE N-ACETYL-P-BENZOQUINONE IMINE (NAPQI) INDEPENDENTLY MAY CAUSE FALSELY LOW LDL-C RESULTS." THE PROVIDED ANALYZER ALARM TRACE CONTAINED NUMEROUS ABNORMAL ASPIRATION ALARMS WHICH ARE INDICATORS OF PREANALYTIC ISSUES. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. PATIENT 2 HAD UROSEPSIS WHICH CAN INFLUENCE LDL RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.