MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT FERRITIN GEN.4

Catalog Number	05172390190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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 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.
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.

• Brand Name: TINA-QUANT FERRITIN GEN.4
• Common Device Name: FERRITIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 23415947
• Report Number: 1823260-2025-04401
• Device Sequence Number: 13398303
• Product Code: DBF
• UDI-Device Identifier: 04015630925308
• UDI-Public: 04015630925308
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K100538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 05172390190
• Device Lot Number: 860902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 11/10/2025; 02/23/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/03/2025; 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AACIDEXAM (INTRAVENOUS, ONCE DAILY); AMBISOME (AMFOTERICINE B) IN 5% GLUCOSE (ONCE/DAY); BACTRIM FORTE TABLET; BIKTARVY ABACUS COMP (TABLET, ONCE DAILY); DAKTARIN 2% CREME (TWICE DAILY); DIAMOX (IV BOLUS, ONCE DAILY); EXACYL (INTRAVENOUS, 3 TIMES DAILY); GANCICLOVIR (CYMEVENE) (INTRAVENOUS, TWICE DAILY); JAKAVI CAPSULE (TWICE DAILY); KINERET (TWICE DAILY); LASIX (INTRAVENOUS, 3 TIMES DAILY); MAGNESIUM SULFATE IN GLUCOSE 5% (ONCE DAILY); MEROPENEM IN NACL 0.9% (IV, 3 TIMES DAILY); MIDAZOLAM; PANTOMED (TABLET, ONCE DAILY); POTASSIUM PHOSPHATE IN 0.9% NACL (ONCE DAILY); REMIFENTANIL; VANCOMYCIN CONTINU INFUSION (ONCE DAILY)
• Patient Sex: Unknown