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	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).No calibration influence was observed.Controls were within range prior to the event.A general reagent or analyzer problem was not present.Non-systematic irreproducible results do not represent a general malfunction of the assay.A review of the alarm trace showed sample quality related alarms, including sample foam detection, sample clot detection, an short sample.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for five patient samples tested with elecsys ferritin on a cobas e 801 analytical unit.The first sample initially resulted in a ferritin value of 39 ng/ml.The sample was repeated twice, resulting in ferritin values of 9.25 ng/ml and 9.44 ng/ml.The second sample initially resulted in a ferritin value of 63.3 ng/ml on (b)(6) 2025.The sample was repeated twice on (b)(6) 2025, resulting in ferritin values of 47.9 ng/ml and 39.3 ng/ml.The third sample initially resulted in a ferritin value of 98.4 ng/ml on (b)(6) 2025.The sample was repeated twice on (b)(6) 2025, resulting in ferritin values of 26.9 ng/ml and 24.9 ng/ml.The fourth sample initially resulted in a ferritin value of 18.1 ng/ml on (b)(6) 2025.The sample was repeated twice on (b)(6) 2025, resulting in ferritin values of 27.3 ng/ml and 29.5 ng/ml.The fifth sample initially resulted in a ferritin value of 28.2 ng/ml on (b)(6) 2025.The sample was repeated three times on (b)(6) 2025, resulting in ferritin values of 40.4 ng/ml, 14.1 ng/ml, and 14.5 ng/ml.
Additional Manufacturer Narrative
The customer provided data for 11 additional patient samples with discrepant ferritin results (samples 6 - 16).Sample 6 initially resulted in a ferritin value of 20.4 ug/l on (b)(6) 2025 and it was repeated three times, resulting in values of 14.0 ug/l, 7.59 ug/l, and 7.33 ug/l.Sample 7 resulted in ferritin values of 110 ug/l and 177 ug/l on (b)(6) 2025.Sample 8 resulted in ferritin values of 10.9 ug/l and 34.5 ug/l on (b)(6) 2025.Sample 9 resulted in ferritin values of 69.8 ug/l and 108 ug/l on (b)(6) 2025.Sample 10 resulted in ferritin values of 30.9 ug/l and 49.7 ug/l on (b)(6) 2025.Sample 11 resulted in ferritin values of 18.2 ug/l and 27.7 ug/l on (b)(6) 2025.Sample 12 resulted in ferritin values of 44 ug/l and 90 ug/l on (b)(6) 2025.Sample 13 resulted in ferritin values of 14.5 ug/l and 39.9 ug/l on (b)(6) 2025.Sample 14 resulted in ferritin values of 17.1 ug/l and 53.5 ug/l on (b)(6) 2025.Sample 15 resulted in ferritin values of 23.5 ug/l and 37.6 ug/l on (b)(6) 2025.Sample 16 resulted in ferritin values of 10.3 ug/l and 52.8 ug/l on (b)(6) 2025.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 23018031
• Report Number: 1823260-2025-02817
• Device Sequence Number: 13148123
• Product Code: JMG
• UDI-Device Identifier: 04015630939688
• UDI-Public: 04015630939688
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/04/2025

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 07027273190
• Device Lot Number: 87106001
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 11/04/2025
• 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