ELECSYS T4
Received Sep 27, 2023 · Event occurred Sep 10, 2023
Report 1823260-2023-03118 · MDR key 17824013
Device
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CALIBRATION AND QUALITY CONTROL DATA RECOVERED WITHIN EXPECTATIONS. UPON REVIEW OF THE ALARM TRACE, A SAMPLE CLOT WAS OBSERVED ON THE DAY OF THE EVENT. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE E 801 MODULE IS (B)(6). MEDWATCH FIELD E1. INITIAL REPORTER EMAIL ADDRESS WAS PROVIDED AS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS T4 ON A COBAS E 801 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A T4 VALUE OF 303 NMOL/L. THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE SAMPLE WAS REPEATED, RESULTING IN A T4 VALUE OF 155 NMOL/L.