ELECSYS BRAHMS PCT

Additional Manufacturer Narrative

THE E402 ANALYZER SERIAL NUMBER WAS (B)(6). SAMPLE MATERIAL WAS REQUESTED FOR INVESTIGATION.

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS BRAHMS PCT (PCT) ON A COBAS E 402 ANALYTICAL UNIT. THE PATIENT WAS TESTED DAILY WITH RESULTS CONSISTENTLY AROUND 2 NG/ML (EXAMPLES PROVIDED WERE 1.89 NG/ML AND 2.11 NG/ML). THE RESULTS WERE "ALWAYS REPEATABLE." THE FOLLOWING SPECIFIC RESULTS WERE PROVIDED: ON (B)(6) 2025, THE RESULT WAS 2.22 NG/ML. ON (B)(6) 2025, THE RESULT WAS 2.49 NG/ML. ON (B)(6) 2025, THE RESULT WAS 1.94 NG/ML. ON (B)(6) 2025, THE RESULT WAS 2.08 NG/ML. ON (B)(6) 2025, THE RESULT WAS 2.18 NG/ML. ON (B)(6) 2025, THE RESULT WAS 1.87 NG/ML. ON (B)(6) 2025, THE RESULT WAS 2.09 NG/ML. ON (B)(6) 2025, THE RESULT WAS 2.09 NG/ML. ON (B)(6) 2025, THE RESULT WAS 2.08 NG/ML. ON (B)(6) 2025, THE RESULT WAS 2.21 NG/ML. ON (B)(6) 2025, THE RESULT WAS 1.91 NG/ML. THE PATIENT HAD BEEN INITIALLY TESTED BY A MINDRAY INSTRUMENT, WHICH PRODUCED SIMILAR RESULTS. A SAMPLE FROM THE PATIENT WAS TESTED AT AN EXTERNAL LABORATORY USING THE VIDAS METHOD, AND THE RESULT WAS ALSO "POSITIVE" (1.27 NG/ML). THE PCT RESULTS ARE IN QUESTION AS NO OTHER TEST RESULTS SUGGEST SEPSIS, THE PATIENT IS WELL WITH NO FEVER, AND THE CRP RESULT WAS "NEGATIVE." THE CUSTOMER SUSPECTS AN INTERFERENCE AFFECTING THE RESULTS.

Additional Manufacturer Narrative

SECTION D4 WAS UPDATED. THE CALIBRATION SIGNALS WERE VERY HIGH COMPARED TO THE EXPECTED SIGNAL COUNTS. THE SAMPLE WAS RECEIVED FOR INVESTIGATION ON 30-JUL-2025, WHERE IT WAS TESTED ON A COBAS E402: PCT RESULT WITHOUT HBT TREATMENT: 1.33 NG/ML. PCT RESULT WITH HBT TREATMENT: 1.31 NG/ML. NO REAGENT-SPECIFIC ISSUE COULD BE IDENTIFIED. THE RESULT WAS CONSIDERED A TRUE VALUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE REAGENT MEETS THE SPECIFICATIONS.