ELECSYS ACTH

Description of Event or Problem

THERE IS A SUSPECTED INTERFERENCE WITH THE ELECSYS ACTH ASSAY DUE TO QUESTIONABLE RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. ON 15-JUN-2022 THE INITIAL RESULT WAS > 2000 PG/ML. THE REPEATED RESULT WAS 39480 PG/ML FOLLOWING A DILUTION. ON 15-SEP-2022 THE INITIAL RESULT WAS > 2000 PG/ML. THE REPEATED RESULT WAS 29000 PG/ML FOLLOWING A DILUTION. ON 10-MAR-2023 THE INITIAL RESULT WAS > 2000 PG/ML. THE REPEATED RESULT WAS 61050 PG/ML FOLLOWING A DILUTION. ON 28-JUL-2023 THE INITIAL RESULT WAS > 2000 PG/ML. THE REPEATED RESULT WAS 7375 PG/ML FOLLOWING A DILUTION. ON 16-JAN-2024 THE INITIAL RESULT WAS > 2000 PG/ML. THE REPEATED RESULT WAS 71850 PG/ML FOLLOWING A DILUTION. THE SAMPLE WAS TESTED USING THE SIEMENS IMMULITE METHOD WITH MULTIPLE DILUTIONS AND THE RESULTS WERE HIGH. THE NUMERIC RESULTS WERE NOT PROVIDED. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

Additional Manufacturer Narrative

THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE CUSTOMER NOTED THAT A HETEROPHILE ANTIBODY INTERFERENCE HAD BEEN RULED OUT. THE FIELD SERVICE REPRESENTATIVE CHECKED ALL PROBES, ADJUSTMENTS, PRESSURES, AND LEVELS. HE PERFORMED MECHANISM CHECKS AND INSTRUMENT CHECKS SUCCESSFULLY. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

IT WAS NOTED THAT THE CUSTOMER'S CALIBRATION SIGNALS WERE SLIGHTLY HIGHER THAN EXPECTED AND THE QC WAS ABOVE EXPECTED LEVELS. SAMPLE SHORT ALARMS WERE OBSERVED IN THE SYSTEM'S ALARM TRACE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

SECTION D4 LOT NUMBER WAS UPDATED. A REAGENT LOT NUMBER WAS PROVIDED FOR THE ALLEGED RESULTS THAT OCCURRED ON (B)(6) 2024.