TOTAL PROTEIN/TOTAL PROTEIN STAT

Additional Manufacturer Narrative

CALIBRATION AND CONTROLS WERE ACCEPTABLE. THE FIELD APPLICATION SPECIALIST VERIFIED THAT CALIBRATION AND CONTROLS WERE ACCEPTABLE. PRECISION STUDIES WERE PERFORMED AND RECOVERED WITHIN SPECIFICATIONS. A COMPARISON EXPERIMENT WAS PERFORMED USING MIXED AND CENTRIFUGED SAMPLES; NO OBSERVABLE DIFFERENCE WAS NOTED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FOUR PATIENT SAMPLES TESTED WITH TOTAL PROTEIN/TOTAL PROTEIN STAT ON A COBAS 6000 C501 MODULE. THE SAMPLES WERE REPEATED THE NEXT DAY AS THE LOW VALUES DID NOT MATCH THE PREVIOUS RESULTS OF THE PATIENTS. THE FIRST SAMPLE INITIALLY RESULTED IN A TOTAL PROTEIN VALUE OF 7.21 G/DL. THE SAMPLE WAS REPEATED, RESULTING IN VALUES OF 8.65 G/DL, 8.65 G/DL, AND 8.89 G/DL. THE SECOND SAMPLE INITIALLY RESULTED IN TOTAL PROTEIN VALUES OF 3.77 G/DL WITH A DATA FLAG AND 3.85 G/DL. THE SAMPLE WAS REPEATED, RESULTING IN VALUES OF 6.49 G/DL AND 6.32 G/DL. THE THIRD SAMPLE INITIALLY RESULTED IN TOTAL PROTEIN VALUES OF 3.07 G/DL WITH A DATA FLAG, 3.07 G/DL, AND 3.13 G/DL. THE SAMPLE WAS REPEATED, RESULTING IN VALUES OF 7.37 G/DL AND 7.09 G/DL. THE FOURTH SAMPLE INITIALLY RESULTED IN TOTAL PROTEIN VALUES OF 1.78 G/DL WITH A DATA FLAG AND 1.91 G/DL. THE SAMPLE WAS REPEATED, RESULTING IN VALUES OF 6.34 G/DL, 6.57 G/DL, AND 6.40 G/DL. THE PATIENTS' RESULTS WERE AMENDED.

Additional Manufacturer Narrative

THE C501 MODULE SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER (FSE) CHECKED MULTIPLE PARTS OF THE INSTRUMENT AND NO ISSUES WERE IDENTIFIED. PRECISION CHECKS WERE WITHIN SPECIFICATION. AN ABNORMAL PROBE-SUCKING ALARM WAS OBSERVED ON THE DAY OF THE EVENT. THE PATIENT SAMPLES IN QUESTION WERE PIPETTED BEFORE AND AFTER THIS ALARM. NO ISSUES WERE OBSERVED DURING A REVIEW OF THE REACTION MONITOR DATA. THE HARDWARE PERFORMANCE CHECK (HPC) WAS WITHIN SPECIFICATION. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A PRE-ANALYTICAL HANDLING ISSUE.