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

Catalog Number	08057931190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number was 877740.The expiration date was not provided.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 initial result was 607 ug/dl.The sample was repeated three times with "sample clot" alarms.The sample was recentrifuged, and the repeat results were 41.4 ug/dl and 42.8 ug/dl.The questionable result was not reported outside of the laboratory.The result of 42.8 ug/dl was believed to be correct.
Additional Manufacturer Narrative
Medwatch fields d1-d4, g1, and g4 were updated.The investigation was unable to determine a specific root cause.Based on the multiple clot alarms obtained on the attempted retesting of the sample, the event is consistent with a preanalytical issue.Correct pre-analytic sample handling is within the customer's responsibility.The provided calibration and qc data were inconspicuous, indicating unaffected performance of the device or assay.There is no evidence to suggest a malfunction of the device.

• 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 46250-0457
• MDR Report Key: 23876433
• Report Number: 1823260-2025-05301
• Device Sequence Number: 9464103
• Product Code: JIY
• UDI-Device Identifier: 07613336121344
• UDI-Public: 07613336121344
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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): 02/06/2026

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: 877740
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/06/2026
• 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