MAUDE Adverse Event Report: ROCHE DIAGNOSTICS RHEUMATOID FACTORS II; CLINICAL CHEMISTRY ANALYZER

Catalog Number	20764574322
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	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot numbers were 82506601 with an expiration of 31-aug-2026 and 80312501 with an expiration date of 31-may-2026.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable rheumatoid factors ii result with one patient sample tested on the cobas 8000 cobas c 502 module.On (b)(6) 2025: the initial result was flagged, which triggered autodilution of the sample.The dilution result was 261.8 iu/ml.On (b)(6) 2025: the repeat results were 18.6 iu/ml, 19.7 iu/ml, and 21.2 iu/ml.The repeat results were deemed correct.
Additional Manufacturer Narrative
Qc and calibration data were within range.A review of the alarm trace revealed that sample clot detection, abnormal aspiration (sample probe), and sample foam detection alarms were present on the date of the event.These are an indication of possible poor sample quality.The instrument was confirmed to be operational with no issues.No further issues were reported.The investigation did not identify a product problem.The cause of the event could not be determined.Medwatch fields d1, d2, d4, g1, and g4 were updated.

• Brand Name: RHEUMATOID FACTORS II
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22807082
• Report Number: 1823260-2025-02503
• Device Sequence Number: 7836947
• Product Code: DHR
• UDI-Device Identifier: 04015630914524
• UDI-Public: 04015630914524
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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 Catalogue Number: 20764574322
• Device Lot Number: 80312501, 82506601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2025
• Supplement Date Received by Manufacturer: 08/23/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/08/2025
• 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