LDL-C GEN.3

Additional Manufacturer Narrative

UNDER THE SECTION "REPLACING THE PHOTOMETER LAMP OF THE C 701 AND C 702 MODULES" PRODUCT LABELING STATES: "IF THE PHOTOMETER LAMP HAS BEEN USED FOR MORE THAN 6 MONTHS (OR 750 HOURS OF POWER-ON TIME) OR IF THE PHOTOMETER CHECK VALUE EXCEEDS 14000 ABSORBANCE UNITS." THE ALARM TRACE SHOWED SEVERAL SAMPLE SHORT ALARMS. IT WAS NOTED THAT ONE INSTRUMENT HAD NON-ROCHE REAGENTS INSTALLED. PRODUCT LABELING STATES: "YOU MUST ONLY USE ACCESSORIES AND CONSUMABLES SPECIFIED FOR THE COBAS 8000 MODULAR ANALYZER SERIES." THE INVESTIGATION FOUND THE ROOT CAUSE TO BE CONSISTENT WITH THE PATIENTS' CONDITIONS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE CUSTOMER'S CALIBRATION WAS OK. ONE OF THE CUSTOMER'S QC LEVELS WAS NOT ACCEPTABLE. IT WAS NOTED THAT THE PHOTOMETER LAMP AND CUVETTES WERE OVERDUE TO BE REPLACED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE LDL-C GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE COMPARED TO A COMPETITOR METHOD. PATIENT 1: THE INITIAL RESULT WAS 15 MG/DL. THE REPEATED RESULT WITH ANOTHER METHOD (AU 680) WAS 116 MG/DL. PATIENT 2: THE INITIAL RESULT WAS 16 MG/DL. THE REPEATED RESULT WAS 14 MG/DL BUT HAD AN INVALIDATING DATA FLAG. THE REPEATED RESULT WITH ANOTHER METHOD (AU 680) WAS 120 MG/DL WITH A DILUTION RATIO OF 1:5.