FERR4
Received Mar 8, 2024 · Event occurred Feb 14, 2024
Report 1823260-2024-00708 · MDR key 18866633
Device
Product problems
- High Test Results
- High Test Results
Patient
42 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CALIBRATION AND QC WERE ACCEPTABLE. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Additional Manufacturer Narrative
THE C303 ANALYZER SERIAL NUMBER WAS (B)(6). COMPETITOR METHOD 1 WAS MINI VIDAS. COMPETITOR METHOD 2 WAS NOT PROVIDED.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR FERR4 ON A COBAS C 303 ANALYTICAL UNIT COMPARED TO TWO COMPETITOR METHODS. ON 14-FEB-2024 THE INITIAL RESULT FROM THE C303 ANALYZER WAS 46.7 NG/ML. ON 15-FEB-2024 THE REPEAT RESULT FROM COMPETITOR METHOD 1 WAS 2.95 NG/ML. THE REPEAT RESULT FROM COMPETITOR METHOD 2 WAS < 3 NG/ML. A NEW SAMPLE WAS OBTAINED AND THE RESULT FROM THE C 303 ANALYZER WAS 49 NG/ML.