FERR4

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS 8000 COBAS C 502 MODULE IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED A QUESTIONABLE FERR4 TINA-QUANT FERRITIN GEN.4 (FERR4) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLE WAS RERUN BECAUSE OF THE TECHNOLOGIST'S OBSERVATION. THE INITIAL RESULT FROM THE MODULE WAS 0.0 UG/L WITH A DATA FLAG. THIS RESULT WAS REPORTED AS 8 UG/L WITH A DATA FLAG. THE FIRST REPEAT RESULT FROM THE MODULE WITH THE PATIENT SAMPLE AUTODILUTED WAS 675.5 UG/L. THE SECOND REPEAT RESULT FROM ANOTHER ANALYZER WAS 663 UG/L. THE REPEAT RESULT WAS DEEMED CORRECT.

Additional Manufacturer Narrative

THE INVESTIGATION REVIEWED THE LAST CALIBRATION PERFORMED ON (B)(6) 2023; THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE QC RECOVERY. THE CUSTOMER'S QC RECOVERY WAS PROVIDED FOR THE DAY OF THE EVENT, BUT THERE WERE NO TIMESTAMPS PROVIDED WITH THE QC. QC LEVELS 1 - 3 WERE HIGH OUT OF RANGE (2 STANDARD DEVIATIONS SD). TWO OF THE MEASUREMENTS WERE WITHIN THE PROVIDED 2 SD RANGE. FOR THE LEVEL 2 QC, ALL OF THE FOUR PROVIDED MEASUREMENTS WERE HIGH AND OUT OF RANGE (2SD). THE FIELD SERVICE ENGINEER INSPECTED THE MODULE AND DID NOT FIND ANY CAUSE FOR THE ISSUE ADDING THAT IT WAS POSSIBLY DUE TO POOR SAMPLE QUALITY. HE THEN CHECKED THE FLOW PATH AND RINSE LEVELS. THE CUSTOMER ALSO REPLACED THE SAMPLE PROBE. THE CUSTOMER PERFORMED CALIBRATION AND QC WITH SUCCESSFUL RESULTS. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. BASED ON THE PROVIDED INFORMATION, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.