ELECSYS BRAHMS PCT
Received Sep 1, 2023 · Event occurred Aug 4, 2023
Report 1823260-2023-02864 · MDR key 17671494
Device
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PROCALCITONIN V2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 CORE UNIT. ON (B)(6) 2023, THE INITIAL RESULT WAS GREATER THAN 100 NG/ML. THE SAMPLE WAS REPEATED AND GAVE A RESULT OF GREATER THAN 100 NG/ML. ON (B)(6) 2023, A 1:3 DILUTION WAS MADE FROM THE INITIAL REFRIGERATED SAMPLE AND THE RESULT WAS 45 NG/ML. THE REFRIGERATED ORIGINAL SAMPLE WAS REPEATED AGAIN AND THE RESULT WAS 48.4 NG/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE ANALYZE SERIAL NUMBER IS (B)(6). IT WAS FOUND THAT THE STABILITY OF THE MEASURED SAMPLES IS 24 HOURS AT 20 TO 25 DEGREES C AND 48 HOURS AT 2 TO DEGREES C. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH THE EXCEEDED STORAGE TIME OF THE SAMPLE FOR THE GIVEN TEMPERATURE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.