TOTAL PROTEIN GEN.2

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER (FSE) FOUND THE CUSTOMER HAD DOWNLOADED NEW H2O CALIBRATOR PARAMETERS BUT ONLY RECALIBRATED THE PRIMARY REAGENT PACK. THE CUSTOMER DID NOT QC THE STANDBY REAGENT PACKS CORRECTLY. THE STANDBY REAGENT PACK FAILED QC BUT THE CUSTOMER DID NOT RESOLVE THE QC ISSUE ON THAT REAGENT PACK. WHEN THE PRIMARY REAGENT PACK RAN OUT AND CHANGED TO THE STANDBY REAGENT PACK, PATIENT RESULTS WERE LOW. AFTER RECALIBRATING THE REAGENT PACK CAUSING THE ISSUE, THE CORRECT RESULTS WERE RECEIVED. A PRECISION CHECK PASSED. THE SAMPLE WAS SPUN DOWN FOR 5 MINUTES AT 3500 REVOLUTIONS PER MINUTE (RPM). THIS SPIN TIME MAY BE SHORTER THAN RECOMMENDED. ABNORMAL PROBE SUCKING, ABNORMAL SAMPLE ASPIRATION, AND SAMPLE SHORT ERRORS WERE OBSERVED ON THE ALARM TRACE DATA. THESE ARE INDICATORS OF POSSIBLE POOR SAMPLE QUALITY. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO THE CUSTOMER'S CALIBRATOR AND QC HANDLING. THE ISSUE WAS RESOLVED BY RECALIBRATING THE AFFECTED REAGENT PACK.

Additional Manufacturer Narrative

THE C501 MODULE SERIAL NUMBER WAS (B)(6).

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR TOTAL PROTEIN GEN.2 (TP2) ON A COBAS 6000 C (501) MODULE. DISCREPANT RESULTS WERE PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 0.7 G/DL. THE REPEAT RESULT FROM A DIFFERENT C501 MODULE WAS 7.1 G/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.