TOTAL PROTEIN/TOTAL PROTEIN STAT

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER FOUND THE TUBING ON THE SYSTEM WAS BRITTLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE INSTRUMENT USED WAS A COBAS 8000 COBAS C 502 MODULE WITH SERIAL NUMBER (B)(6). FURTHER INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY AND MEDICATION WAS REQUESTED BUT NOT YET PROVIDED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE TP2 (TOTAL PROTEIN) ASSAY RESULTS FOR A PATIENT SAMPLE TESTED ON A COBAS 8000 COBAS C 502 MODULE THAT DID NOT MATCH THE RESULTS OF THE ALBUMIN AND IGGAM MEASUREMENTS OF THE SAME SAMPLE. IT WAS ALLEGED THAT THE INDIVIDUAL RESULTS OF ALBUMIN, IGM, AND IGA WOULD SUGGEST A HIGHER CONCENTRATION OF TOTAL PROTEIN IN TOTAL. THE CUSTOMER SUSPECTED AN INTERFERENCE. THE INITIAL RESULT WAS 34.6 G/L. THE REPEAT RESULT ON (B)(6) 2024 WAS 35.2 G/L AND ON (B)(6) 2024 WAS 35.7 G/L. THE TOTAL PROTEIN RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORAORY.