ELECSYS BRAHMS PCT
Received Dec 4, 2023 · Event occurred Oct 15, 2023
Report 1823260-2023-03832 · MDR key 18256723
Device
Product problems
- High Test Results
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THE INITIAL REPORTER QUESTIONED HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT TESTED FOR ELECSYS BRAHMS PCT (PCT) ON A COBAS E 601 MODULE. THE PATIENT REPORTEDLY HAD "VERY HIGH" PCT RESULTS FOR "SEVERAL DAYS" (E.G. 90 NG/ML). MULTIPLE SAMPLES WERE OBTAINED FROM THE PATIENT SINCE "MID-OCTOBER" AND THE RESULTS WERE GREATER THAN 25 NG/ML. THE SAMPLES WERE NOT REPEATED ON OTHER INSTRUMENTS. THE PCT RESULTS DECREASED SINCE. ON (B)(6) 2023 THE RESULT WAS 63 NG/ML. ON (B)(6) 2023 THE RESULT WAS 47 NG/ML. ON (B)(6) 23023 THE RESULT WAS 34 NG/ML.
Additional Manufacturer Narrative
THE E601 MODULE SERIAL NUMBER WAS (B)(6). CALIBRATION AND QC WERE ACCEPTABLE. IT WAS NOTED THAT PCT IS PRODUCED IN THE C-CELLS OF THE THYROID AND IS KNOWN TO BE ELEVATED IN THE ABSENCE OF INFECTION IN PATIENTS WITH THYROID DISEASE OR DYSFUNCTION. THE INVESTIGATION IS ONGOING.