TINA-QUANT APOLIPOPROTEIN A-1 VER.2

Additional Manufacturer Narrative

QC WAS WITHIN THE ACCEPTABLE RANGE. NO ISSUES WERE IDENTIFIED WITH THE CUSTOMER'S CURRENT CALIBRATION. MANY SAMPLE SHORT ALARMS WERE OBSERVED ON THE ALARM TRACE DATA. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED, HOWEVER, BASED ON THE INFORMATION PROVIDED, THE EVENT IS CONSISTENT WITH AN ISSUE WITH THE SAMPLE PROBE DUE TO PREANALYTICAL HANDLING ISSUES AND/OR INSUFFICIENT PROBE WASH. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR TINA-QUANT APOLIPOPROTEIN A-1 VER.2 (APOAT) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.489 G/L. THE SAMPLE WAS REPEATED BY A COMPETITOR METHOD AND THE RESULT WAS "DISCREPANT." THE SPECIFIC RESULT WAS NOT PROVIDED. THE SAMPLE WAS REPEATED ON THE C503 ANALYZER USING A 1:2 DILUTION AND THE RESULT WAS 0.85 G/L. A NEW SAMPLE WAS OBTAINED AND THE INITIAL RESULT ON THE C503 ANALYZER WAS 0.8 G/L. THE SAMPLE WAS REPEATED USING A 1:2 DILUTION AND THE RESULT WAS 0.924 G/L.

Additional Manufacturer Narrative

THE C503 ANALYZER SERIAL NUMBER WAS (B)(6).