TINA-QUANT FERRITIN GEN.4
Received Oct 29, 2025 · Event occurred Sep 2, 2025
Report 1823260-2025-04401 · MDR key 23415947
Device
Product problems
- Low Test Results
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT FERRITIN GEN.4 ON COBAS 8000 C702 MODULE ANALYZERS. THE SAMPLE WAS FIRST TESTED ON THE FIRST C 702 ANALYZER, RESULTING IN A FERRITIN VALUE OF 900 UG/L. THE SAMPLE WAS REPEATED ON (B)(6) 2025 ON THE SAME ANALYZER, RESULTING IN A VALUE OF 962.7 UG/L. THE SAMPLE WAS REPEATED ON A SECOND C 702 ANALYZER ON (B)(6) 2025, RESULTING IN A FERRITIN VALUE OF 862.1 UG/L. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AFTER A 1:50 DILUTION, RESULTING IN A VALUE OF 179098 UG/L ACCOMPANIED BY A DATA FLAG INDICATING AN ISSUE WITH REACTION KINETICS. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER USING DECREASED SAMPLE VOLUME, RESULTING IN A VALUE OF 24280 UG/L ACCOMPANIED BY A DATA FLAG INDICATING AN ISSUE WITH REACTION KINETICS. THE CUSTOMER ALLEGES THAT THE LOWER FERRITIN VALUES WERE NOT FLAGGED TO INDICATE THERE WERE PROZONE ISSUES WITH THE SAMPLE.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE FIRST C 702 ANALYZER WAS (B)(6). THE SERIAL NUMBER OF THE SECOND C 702 ANALYZER WAS REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THE PATIENT'S FERRITIN CONCENTRATION LIKELY EXCEEDED THE HIGH-DOSE HOOK EFFECT LIMIT OF THE ASSAY. PRODUCT LABELING SPECIFIES THE HIGH-DOSE HOOK LIMIT AS 80000 UG/L. AN INTERFERENCE CAUSED BY THE PATIENT'S EXTENSIVE MEDICATION CANNOT BE RULED OUT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE.
Additional Manufacturer Narrative
THE CUSTOMER PROVIDED DATA FOR TWO ADDITIONAL SAMPLES (SAMPLES 2 AND 3) FROM THE SAME PATIENT WITH DISCREPANT FERRITIN RESULTS. SAMPLE 2 INITIALLY RESULTED IN A FERRITIN VALUE OF 2495 UG/L WITH A DATA FLAG ON (B)(6) 2025. THIS SAMPLE WAS DILUTED 1:8, RESULTING IN A VALUE OF 26453 UG/L WITH A DATA FLAG. THE SAMPLE WAS DILUTED 1:50, RESULTING IN A VALUE OF 119042 UG/L WITH A DATA FLAG. SAMPLE 3 INITIALLY RESULTED IN A FERRITIN VALUE OF 1497 UG/L WITH A DATA FLAG ON (B)(6) 2025. THIS SAMPLE WAS DILUTED 1:8, RESULTING IN A VALUE OF 23260 UG/L WITH A DATA FLAG. THE SAMPLE WAS DILUTED 1:50, RESULTING IN A VALUE OF 175032 UG/L WITH A DATA FLAG. MEDWATCH FIELDS B3, D1, D2, D4, D10, AND G4 HAVE BEEN UPDATED.