LDL-C GEN.3

Additional Manufacturer Narrative

HDLC4 PRODUCT LABELING STATES: "ASCORBIC ACID UP TO 50 MG/DL (2.84 MMOL/L) DOES NOT INTERFERE." LDL_C PRODUCT LABELING STATES: "ASCORBIC ACID UP TO 50 MG/DL (2.84 MMOL/L) DOES NOT INTERFERE." CALIBRATION DATA WAS PROVIDED FOR 15-DEC-2022 AND NO ISSUES WERE IDENTIFIED. QC ON THE DAY OF THE EVENT WAS ACCEPTABLE. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. NO PRE-ANALYTICAL ISSUES WERE IDENTIFIED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR LDL_C LDL-CHOLESTEROL PLUS 2ND GENERATION (LDL_C) ON A COBAS 8000 C 702 MODULE COMPARED TO A NON-ROCHE METHOD. OF THE DATA PROVIDED, DISCREPANT RESULTS FOR HDL-CHOLESTEROL GEN.4 (HDLC4) WERE IDENTIFIED. THIS MEDWATCH WILL COVER LDL_C. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE HDLC4 RESULTS. THE LDL_C RESULT FROM THE C702 MODULE WAS 97.6 MG/DL THE LDL CHOLESTEROL RESULT FROM THE NON-ROCHE METHOD WAS 316.0 MG/DL. THE HDLC4 CHOLESTEROL RESULT FROM THE C702 MODULE WAS 50.1 MG/DL. THE HDL CHOLESTEROL RESULT FROM THE NON-ROCHE METHOD WAS 27.9 MG/DL. THE CUSTOMER MENTIONED THE PRODUCT LABELING LISTS AN INTERFERENCE STATEMENT RELATED TO ASCORBIC ACID. IT WAS ASKED BUT IT IS NOT KNOWN IF THE PATIENT IS TAKING ASCORBIC ACID. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE C702 MODULE SERIAL NUMBER WAS (B)(4).

Additional Manufacturer Narrative

AS CALIBRATION AND QC WERE WITHIN SPECIFICATION AND INSTRUMENT MAINTENANCE IS PERFORMED ON A REGULAR BASIS, AN INSTRUMENT ISSUE CAN BE EXCLUDED. THE REAGENT IS WORKING WITHIN SPECIFICATION. BASED ON THE INFORMATION PROVIDED, POSSIBLE INTERFERENCE WITH NITROGLYCERIN CAN BE EXCLUDED. PRODUCT LABELING ADDRESSES ASCORBIC ACID AS AN INTERFERING SUBSTANCE. IT IS UNCLEAR IF THE PATIENT WAS RECEIVING ASCORBIC ACID. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A PATIENT SAMPLE-RELATED ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE SUSPECT MEDICAL DEVICE WAS UPDATED. RELEVANT FIELDS OF SECTIONS D AND G WERE UPDATED. THE INITIAL REPORT STATED: "THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR LDL_C LDL-CHOLESTEROL PLUS 2ND GENERATION (LDL_C) ON A COBAS 8000 C 702 MODULE COMPARED TO A NON-ROCHE METHOD." THIS SHOULD SAY: "THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR LDL-CHOLESTEROL GEN.3 (LDLC3) ON A COBAS 8000 C 702 MODULE COMPARED TO A NON-ROCHE METHOD." NOTE: ANY PREVIOUS REFERENCE TO LDL_C SHOULD ACTUALLY BE LDLC3. LDLC3 PRODUCT LABELING STATES: "ASCORBIC ACID: NO SIGNIFICANT INTERFERENCE FROM ASCORBIC ACID UP TO A CONCENTRATION OF 500 MG/DL (28.4 MMOL/L)."