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

Catalog Number	08057931190
Medical Device Problem Codes	Unable to Obtain Readings (1516); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable iron gen.2 results from the cobas c 503 analytical unit.The customer suspected a possible interference in the sample.The first five samples from this patient had no alarm.Thereafter, seven consecutive samples from the patient had an alarm indicating "the calculated values exceed the defined limit.".Three subsequent samples from the patient had no alarm.No specific numeric results were provided.The customer noted that when the patient stopped taking mucomyst (acetylcysteine), the alarm was not issued.
Additional Manufacturer Narrative
Results for 15 samples from the patient, dating from 24-oct-2025 through 30-oct-2025, were provided.Refer to the attachment to the medwatch for the patient data.Additional information was provided that the patient received desferal from approximately 26-oct-2025 around 15:00 for 22 hours, thereafter in a lower dose until 28-oct-2025 around 08:00.The mucomyst was received on 25-oct-2025 at approximately 12:00 until 29-oct-2025 in the late morning.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not determine a specific root cause.The event was consistent with a physiological issue due to the high levels of iron in combination with the medications.In this case, the patient¿s severe liver injury likely released massive amounts of ferritin, but the primary cause of the flag was the administration of medication.As a metal-binding drug, desferal competes with the assay reagents, preventing iron from reacting at the expected rate.Per product labeling for the assay: in patients treated with iron supplements or metal-binding drugs, the drug-bound iron may not properly react in the test, resulting in artificially low values.In the presence of high ferritin concentrations > 1200 g/l the assumption that serum iron is almost completely bound to transferrin is not valid anymore.Additionally, acetylcysteine (mucomyst), likely administered in rather high doses to counteract the high acetaminophen levels, can contribute to abnormal kinetics/potentially low results.As some of the results had a data flag indicating a sample clot, pre-analytical issues could be present in the lab.Correct pre-analytic sample handling is within the customer's responsibility.

• 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: 23647689
• Report Number: 1823260-2025-04845
• Device Sequence Number: 9961788
• Product Code: JIY
• UDI-Device Identifier: 07613336121344
• UDI-Public: 07613336121344
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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
• Report Date (Section B): 01/09/2026

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: ASKU
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 12/09/2025; 01/07/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/23/2025; 01/09/2026
• 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