FERR4

Additional Manufacturer Narrative

THERE WERE NO ALARMS ON THE LAST CALIBRATIONS PERFORMED ON 13-JUN-2023 AND 14-JUN-2023. QUALITY CONTROL RECOVERY WAS WITHIN RANGE. THERE WAS NO INDICATION OF A REAGENT PERFORMANCE ISSUE. UPON REVIEW OF THE ALARM TRACE, MULTIPLE ABNORMAL ASPIRATION ALARMS WERE OBSERVED. THIS IS AN INDICATION OF POSSIBLE POOR SAMPLE QUALITY. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE COBAS PRO C 503 ANALYTICAL UNIT WAS (B)(6). THE FIELD SERVICE ENGINEER REPLACED THE REACTION CELLS AND RAN PRECISION STUDIES. CONTROLS WERE TESTED AND ALL RESULTS WERE WITHIN THE CUSTOMER'S SPECIFIED RANGES EXCEPT FOR ONE LEVEL OF CONTROL TESTED WITH A NEW LOT OF FERRITIN REAGENT.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH FERR4 (FERRITIN) ON A COBAS PRO C 503 ANALYTICAL UNIT. THE CUSTOMER NOTED THAT CONTROLS WERE RUNNING HIGH WITH A NEW LOT OF FERRITIN REAGENT. THE SAMPLE INITIALLY RESULTED IN A FERRITIN VALUE OF 7 NG/ML. CONTROLS TESTED AFTER THE INITIAL SAMPLE RUN WERE OUTSIDE OF RANGE, SO THE SAMPLE WAS REPEATED. THE SAMPLE REPEATED WITH A FERRITIN VALUE OF 11 NG/ML. THIS REPEAT VALUE WAS DEEMED CORRECT AND A CORRECTED REPORT WAS ISSUED.