MAUDE Adverse Event Report: Roche Diagnostics Iron Gen.2; Photometric Method, Iron (Non-Heme)

Catalog Number	08057931190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with iron gen.2 on a cobas pure c 303 analytical unit.No questionable results were reported outside of the laboratory.The sample initially resulted in an iron value of 23.9 mg/dl.Per laboratory protocol, the customer repeats all samples that initially result in an iron value of < 25 mg/dl.The sample was repeated and the result was 23.9 mg/dl.Since the results did not match the patient's history, the sample was repeated two additional times.The additional iron repeat values were 36.3 mg/dl and 39 mg/dl.
Additional Manufacturer Narrative
The serial number of the c 303 analyzer is (b)(6).The field service engineer cleaned the water tank, probes, and syringe lines.Calibration and controls passed.Patient samples and precision studies were run and no further discrepancies were observed.The investigation is ongoing.

• Brand Name: Iron Gen.2
• Common Device Name: Photometric Method, Iron (Non-Heme)
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50947871
• Report Number: 1823260-2026-04028
• Device Sequence Number: 18749170
• Product Code: JIY
• UDI-Device Identifier: 07613336121344
• UDI-Public: 07613336121344
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K951595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 08057931190
• Device Lot Number: 93475901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/30/2026
• 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
• Patient Sex: Unknown