ELECSYS T4

Additional Manufacturer Narrative

THE COBAS E801 IMMUNOASSAY ANALYZER SERIAL NUMBER WAS (B)(6). THE CUSTOMER USES A 3RD PARTY QC. QC WAS PERFORMED ON THE MORNING OF THE EVENT AND WAS ACCEPTABLE. ON (B)(6)2023 A NEW REAGENT PACK WAS LOADED. THE FIELD SERVICE ENGINEER (FSE) FOUND BUBBLES IN THE REAGENT. THE CUSTOMER REMOVED THE BUBBLES. THE FSE VERIFIED THE REAGENT AND IT WAS PERFORMING WITHIN SPECIFICATIONS. INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESYULTS FOR 1 PATIENT'S SERUM SAMPLE TESTED WITH ELECSYS THYROXINE (T4) ON A COBAS E801 IMMUNOASSAY ANALYZER. INITIAL RESULT: 18 G/DL. THIS RESULT WAS CONSIDERED HIGH AND IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. REPEAT RESULT: 7.66 G/DL. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY BUT THE CUSTOMER NOTICED AND DELETED IT FROM THE PATIENT'S RECORD BEFORE THE PHYSICIAN ACCESSED THE RESULT. THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

Additional Manufacturer Narrative

THE LAST CALIBRATION WAS PERFORMED ON (B)(6) 2023 AND IT WAS ACCEPTABLE. THE ALARM TRACE NOTED MULTIPLE REAGENT SHORT ALARMS AND SAMPLE SHORT ALARMS ON THE DATE OF THE EVENT NEAR THE TIME THE SAMPLE WAS PROCESSED. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT.