MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IRON GEN.2; PHOTOMETRIC METHOD, IRON (NON-HEME)

Catalog Number	05169291190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c702 module serial number was (b)(6).
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for iron gen.2 (iron2) on a cobas 8000 c702 module.The initial result from the c702 module was 545 ug/dl.The doctor questioned this result.On (b)(6) 2025, the sample was tested by the beckman method with a result of 267 ug/dl.The result from the beckman method was believed to be correct.On (b)(6) 2025, the customer diluted the sample to test for interference, and the following results were obtained: 1:3 dilution = 611 ug/dl, 1:5 dilution = 620 ug/dl, 1:10 dilution = 564 ug/dl, 1:50 dilution = 419 ug/dl.The customer suspects an interference affecting the roche results.
Additional Manufacturer Narrative
Section b6 was updated.Section d10, medication, was updated.The patient's sample was a dark brown color.
Additional Manufacturer Narrative
Section b6 was updated.
Additional Manufacturer Narrative
Sections a2 and a3a were updated.Section b6 was updated.It was confirmed that the patient does not take iron supplements.Additionally, the patient has not received a transfusion and has no history of bleeding.The patient's sample was a dark brown color.The brown color is due to the eltrombopag medication taken by the patient.The customer used a centrifugation time of 7 minutes, which may be low.Qc was acceptable, and no instrument alarms occurred.Based on the patient's age, gammopathy can be excluded.Sample material was requested for investigation but was not provided.As the sample was not available for investigation, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: IRON GEN.2
• Common Device Name: PHOTOMETRIC METHOD, IRON (NON-HEME)
• 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
• MDR Report Key: 22914263
• Report Number: 1823260-2025-02648
• Device Sequence Number: 15717118
• Product Code: JIY
• UDI-Device Identifier: 04015630925049
• UDI-Public: 04015630925049
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K951595
• 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,Followup
• Report Date (Section B): 12/03/2025

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 05169291190
• Device Lot Number: 874448
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 09/01/2025; 09/29/2025; 11/04/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/22/2025; 10/20/2025; 12/03/2025
• 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: ELTROMBOPAG; FOSTAMITINIB; LISINOPRIL; METFORMIN; PITAVASTATINA
• Patient Age: 50 YR
• Patient Sex: Male