TOTAL PROTEIN GEN.2

Additional Manufacturer Narrative

THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC WERE ACCEPTABLE. HOWEVER, NO QC DATA WAS PROVIDED FROM 01-MAR-2026. IT WAS NOTED THAT THE SAMPLE'S (SAMPLE 1) GEL LAYER WAS POORLY SEPARATED AND CONTAMINATED WITH ERYTHROCYTES. THE FIELD SERVICE REPRESENTATIVE PERFORMED VISUAL INSPECTIONS AND CHECKS. HE FOUND THAT THE SOLENOID VALVE FOR THE SAMPLE SYRINGES WAS RUSTED. HE CLEANED THE SOLENOID VALVES FOR ALL OF THE SYRINGES AND REPLACED ONE OF THE VALVES. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. SAMPLE 1: THE INITIAL RESULT WAS 0.2 G/DL, AND THE REPEATED RESULT WAS 6.8 G/DL. THE SAMPLE WAS REPEATED BECAUSE THE INITIAL RESULT DIDN'T MATCH THE PATIENT'S CLINICAL HISTORY. SAMPLE 2: ON (B)(6) 2026, THE INITIAL RESULT WAS 0.4 G/DL, AND THE REPEATED RESULT WAS 7.5 G/DL.

Additional Manufacturer Narrative

ADDITIONAL QUESTIONABLE RESULTS WERE PROVIDED FOR TOTAL PROTEIN FOR ONE ADDITIONAL PATIENT. SAMPLE 3'S INITIAL TOTAL PROTEIN RESULT ON 01-MAR-2026 WAS 0.0 G/DL. THE REPEAT RESULT ON ANOTHER ANALYZER WAS 7.03 G/DL. THE ALARM TRACE SHOWED "ABNORMAL ASPIRATION" ALARMS. THE FIELD SERVICE REPRESENTATIVE PERFORMED MULTIPLE CHECKS AND TESTS WITH ACCEPTABLE RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE INVESTIGATION DETERMINED THE ISSUE WAS CONSISTENT WITH PRE-ANALYTICAL HANDLING ISSUES.