MAUDE Adverse Event Report: ROCHE DIAGNOSTICS RF-II; SYSTEM, TEST, RHEUMATOID FACTOR

Catalog Number	05480167190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable rf-ii rheumatoid factors ii results for 1 patient on a cobas 8000 cobas c 701 module.On (b)(6) 2024, the initial serum sample result was 23.4 iu/ml with flag.The sample was repeated and the result was 0.00 iu/ml.A 1:20 dilution was made of the sample and tested and the result was 63.3 iu/ml.On (b)(6) 2024, the sample was repeated again and the result was 6.7 iu/ml accompanied by a flag indicating the value is above the linearity/measuring range of the assay.A 1:5 dilution was made of the sample and tested and the result was 23.3 iu/ml.A 1:10 dilution was made of the sample and tested and the result was 20.2 iu/ml.The sample was also tested on another standby reagent pack of the same lot and the result was 2.4 iu/ml accompanied by a flag indicating the value is above the linearity/measuring range of the assay.Two 1:5 dilutions were made of the sample and tested and both results were 0.0 iu/ml.On (b)(6) 2024, another patient serum sample was tested and the rf-ii result was 6.1 iu/ml.A 1:5 dilution was made of the sample and tested and the result was 18.0 iu/ml.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).An interfering factor in the patient samples is suspected.The investigation is ongoing.
Additional Manufacturer Narrative
Quality control data showed imprecision, which may indicate hardware issues.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: RF-II
• Common Device Name: SYSTEM, TEST, RHEUMATOID FACTOR
• 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: 20363026
• Report Number: 1823260-2024-02878
• Device Sequence Number: 18539857
• Product Code: DHR
• UDI-Device Identifier: 04015630927357
• UDI-Public: 04015630927357
• Combination Product (Y/N): Y
• Initial Reporter Country: CI
• PMA/510(K) Number: K000534
• 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): 10/28/2024

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: 09/30/2025
• Device Catalogue Number: 05480167190
• Device Lot Number: 75233901
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/28/2024
• 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 Sex: Unknown