MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FERRITIN - 100 KIT; FERRITIN ASSAY

Catalog Number	03737551160
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e cobas e 411 analyzer (rack system) serial number is (b)(6).The field service engineer investigated the event and determined it was possibly related to patient sample integrity.He reviewed the customer's calibration, qc, and 21-cup precision check.He checked the alignments, system volume check, sensor readings, and the liquid level detection voltage.He verified the analyzer's performance with a precision check.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable result elecsys ferritin (ferritin) assay result from one patient sample tested on the cobas e 411 analyzer (rack system).The initial result of the patient's first sample was 0.846 ng/ml with a data flag.The repeat result was 332.0 ng/ml.The result of the patient's second sample was 334.2 ng/ml.The nurse questioned the initial result, prompting the patient's sample to be rerun.The repeat result was deemed correct.
Additional Manufacturer Narrative
The calibration results are acceptable.The qc results are acceptable.The alarm trace did not indicate any issues.The patient sample was centrifuged for 5 to 10 minutes; the centrifugation time may be shorter than the recommended time if the patient sample was centrifuged for less than 10 minutes.A general reagent problem was not present because the qcs before the event were within the specified ranges; isolated non-reproducible results also do not represent a general malfunction of the assay.The event's cause could not be determined based on the information provided.The investigation did not identify a product problem.

• Brand Name: ELECSYS FERRITIN - 100 KIT
• Common Device Name: FERRITIN ASSAY
• 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: 22125323
• Report Number: 1823260-2025-01698
• Device Sequence Number: 15627637
• Product Code: JMG
• UDI-Device Identifier: 04015630938940
• UDI-Public: 04015630938940
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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: 03737551160
• Device Lot Number: 82140605
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/23/2025
• 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