LDL_C LDL-CHOLESTEROL PLUS 3ND GENERATION

Additional Manufacturer Narrative

UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER RECEIVED A QUESTIONABLE LOW LDL_C LDL-CHOLESTEROL PLUS 3RD GENERATION RESULT WHEN COMPARED TO THE RESULTS FROM A BECKMAN COULTER AU640 ANALYZER. THE RESULT FROM THE COBAS 8000 C 502 MODULE WAS 1.93 MMOL/L AND THE RESULT FROM THE AU640 WAS 5.53 MMOL/L. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SAMPLE WAS INSPECTED AND WAS FOUND TO BE LIPEMIC. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE CALIBRATION AND QC DATA PROVIDED, A GENERAL REAGENT ISSUE WAS EXCLUDED. REVIEW OF THE PROVIDED REACTION DATA INDICATED THE ISSUE WAS RELATED TO THE HIGH TRIGLYCERIDE CONCENTRATION IN THE SAMPLE. IT WAS NOTED THE CUSTOMER WAS USING A TOO SHORT CENTRIFUGATION TIME WHICH MAY HAVE AFFECTED THE SAMPLE QUALITY. THE CUSTOMER WAS ALSO NOT USING THE SAMPLE CUP ADAPTERS WHICH MAY HAVE CAUSED A SAMPLING ERROR. THE SERIAL NUMBER OF THE COBAS 8000 C 502 MODULE WAS REQUESTED BUT WAS NOT PROVIDED.