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

Catalog Number	10059605190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The data for the investigation was requested, but was not provided.The customer changed the reagent cassette.No further issues were reported after changing the reagent cassette.The investigation determined that the issue was isolated to that specific cassette and was consistent with contamination, storage, or temperature issues.The cause of the event could not be determined.
Additional Manufacturer Narrative
The iron2 reagent expiration date was not provided.The integra 400 plus analyzer serial number was (b)(6).The qc was within the assigned ranges prior to the sample measurement.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with iron gen.2 (iron2) assay on an integra 400 plus analyzer.Initial result: 200 g/dl.The customer questioned the initial result and repeated the sample.Repeat result: 100 g/dl.No questionable results were reported outside the laboratory.

• 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: 22059736
• Report Number: 1823260-2025-01561
• Device Sequence Number: 20949553
• Product Code: JIY
• UDI-Device Identifier: 07613336226803
• UDI-Public: 07613336226803
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 06/25/2025

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 Catalogue Number: 10059605190
• Device Lot Number: 856174
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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
• Patient Sex: Unknown