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	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e801 module serial number was (b)(6).The qc was in range.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 3 patient samples tested with elecsys ferritin (ferr) assay on a cobas e801 module.The reporter provided two examples of discrepant results: sample 1 (patient 1): initial result: 55.1 ug/l.1st repeat result: 25.8 ug/l.2nd repeat result: 25.2 ug/l.Sample 2 (patient 2): initial result: 116 ug/l.Repeat result: 69.4 ug/l.The customer noticed that the initial results were high.No questionable results were reported outside the laboratory and the samples were repeated.The repeat results were reported to the patients.
Additional Manufacturer Narrative
The calibration signals were within expectations.The 31-dec-2024 to 28-jan-2025 alarm trace showed daily multiple-sample foam detection, sample clot detection, and sample short alarms.Images of the samples were reviewed and no sample quality issues were observed.A general reagent problem can be excluded because the qc before the event was within ranges.Based on the information provided, the investigation did 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21138260
• Report Number: 1823260-2025-00109
• Device Sequence Number: 20540566
• 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): 03/04/2025

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: 01/31/2026
• Device Catalogue Number: 07027273190
• Device Lot Number: 81715001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 03/04/2025
• 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