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

Catalog Number	07027273190
Medical Device Problem Codes	High Test Results (2457); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e801 analytical unit serial number was (b)(6).The calibration was last performed on (b)(6) 2024 and it was acceptable.Qc was within range on the day of the event.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 3 patients' serum/plasma samples tested with elecsys ferritin (ferr) assay on a cobas e801 immunoassay analyzer when compared to a chemiluminescence methodology at a different facility.Sample 1 (patient 1): initial result: 737 ng/ml.1st repeat result: 709 ng/ml.2nd repeat result: 422.2 ng/ml (tested with chemiluminescence).Sample 2 (patient 2): initial result: 375 ng/ml.1st repeat result: 359 ng/ml.2nd repeat result: 232.0 ng/ml (tested with chemiluminescence).Sample 3 (patient 3): initial result: 174 ng/ml.Repeat result: 92.8 ng/ml (tested with chemiluminescence).The customer questioned the initial results and repeated the samples.The initial results were considered correct and reported outside the laboratory.Only 1 patient questioned their result.
Additional Manufacturer Narrative
There is no indication of a reagent issue since the qc was within the target ranges.No problem was detected since the customer considered the higher results (tested with elecsys ferr assay) correct.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials, 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19792657
• Report Number: 1823260-2024-02104
• Device Sequence Number: 20602388
• Product Code: JMG
• UDI-Device Identifier: 04015630939688
• UDI-Public: 04015630939688
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• 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): 09/04/2024

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: 04/30/2025
• Device Catalogue Number: 07027273190
• Device Lot Number: 76245601
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/04/2024
• 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 Age: 33 YR
• Patient Sex: Male