MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FERRITIN; FERRITIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number	07027273190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys ferritin results for three patient samples tested on a cobas e 801 analytical unit.Patient 1 - separate samples were tested: on (b)(6) 2025, the result was 164 ng/ml using the siemens assay.On (b)(6) 2025, the result was 223 ng/ml using the siemens assay.On (b)(6) 2025, the result was 587 ng/ml using the elecsys assay.Patient 2 - two samples from the same patient were tested: on (b)(6) -2025, the result was 602 ng/ml using the elecsys assay.On the same day, the same sample was repeated at an external laboratory and the result was 341 ng/ml using a chemiluminescence immunoassay.On (b)(6) 2025, the result was 373 ng/ml using the elecsys assay.On the same day, the same sample was repeated at an external laboratory and the result was 212 ng/ml using a chemiluminescence immunoassay.Patient 3 - separate samples were tested: on (b)(6) 2025, the result was 392 ng/ml using the siemens assay.On (b)(6) 2025, the result was 508 ng/ml using the elecsys assay.On (b)(6) 2025, the result was 616 ng/ml using the elecsys assay.On (b)(6) 2025, the result was 38.4 ng/ml, performed by an external laboratory.On (b)(6) 2025, the result was 590 ng/ml using the elecsys assay.On (b)(6) 2025, the result was 369.4 ng/ml, performed by an external laboratory 1.On (b)(6) 2025, the result was 390 ng/ml, performed by an external laboratory 2.It was reported that the results of patients 1 and 3 did not match the clinical status of the patients.
Additional Manufacturer Narrative
The serial number of the analyzer is: (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Additional patient-related information and results were provided.Medwatch field b7 was updated.New extractions from the same patients were used for the latest results from (b)(6) 2025: patient 1: 282 ng/ml using the e801.Patient 2: 913 ng/ml using the e801 (accompanied with a data flag).A new sample was tested at an external lab and the result was 742 ng/ml.Patient 3: 238 ng/ml using the e801.A new sample was tested at an external lab and the result was 149 ng/ml the above 3 samples generated on the e801 were sent for investigation.The customer values could be reproduced on the cobas e 801 and were also confirmed with a second ferritin method on cobas c module.The customer's qc data are within range and comparable to peer data.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and the standardization methodology used.The investigation did not identify a product problem.

• Brand Name: ELECSYS FERRITIN
• Common Device Name: FERRITIN IMMUNOLOGICAL TEST SYSTEM
• 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: 23594548
• Report Number: 1823260-2025-04708
• Device Sequence Number: 9641054
• Product Code: JMG
• UDI-Device Identifier: 04015630939688
• UDI-Public: 04015630939688
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K971833
• 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): 03/13/2026

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 07027273190
• Device Lot Number: 83924901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 03/13/2026
• 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