LDL-CHOLESTEROL GEN.3

Additional Manufacturer Narrative

QC AND CALIBRATION WERE ACCEPTABLE. THE SERUM SAMPLE SHOWED NO VISUAL ABNORMALITIES REGARDING HEMOLYSIS, LIPIDS, OR FIBRIN CLOTS. THE INSTRUMENT WAS CONFIRMED TO BE PERFORMING WITHOUT ISSUES. NO MAINTENANCE WORK WAS PERFORMED ON THE UNIT DURING THIS PERIOD. THE CUSTOMER LATER CONFIRMED THAT THE ISSUE WAS DUE TO A LAB INTERNAL HANDLING ERROR WITH DILUTIONS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS WITH MULTIPLE ASSAYS FOR A PATIENT SAMPLE TESTED ON THE COBAS INTEGRA 400 PLUS. THIS MEDWATCH WILL APPLY TO THE LDL ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE LIPASE ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CHOLESTEROL ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE HDL ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TRIGLYCERIDES ASSAY. INITIAL RESULTS: LIPASE: 8,859 U/L, CHOLESTEROL: 4,074 MG/DL , HDL: 1,611 MG/DL , LDL: 2,077 MG/DL , TRIGLYCERIDES: 3,133 MG/DL. REPEAT RESULTS: LIPASE: 4,678 U/L, CHOLESTEROL: 167 MG/DL , HDL: 69 MG/DL , LDL: 88 MG/DL , TRIGLYCERIDES: 133 MG/DL. REPEAT RESULTS AFTER A 1:10 MANUAL DILUTION: CHOLESTEROL: 196 MG/DL, HDL: 80 MG/DL , LDL: 101 MG/DL , TRIGLYCERIDES: 154 MG/DL.