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

Catalog Number	05480167190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable rheumatoid factor results for one patient sample tested on a cobas 8000 c702 module.The initial result analyzed on a sample aliquot from cobas c8100 preanalytical system was 78 iu/ml all reanalysis was done on the primary tube.The first repeat result was 66.9 iu/ml with a data flag.The second repeat result with decreased sample volume was 409 iu/ml with a data flag.The third repeat result with a 1:50 dilution was 4525 iu/ml.The discrepancy was immediately discovered since the patient's previous measured result was 3883 iu/ml.The erroneous result was not released from the lab.
Additional Manufacturer Narrative
The cobas 8000 c702 module serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.As the qc and calibration were acceptable, no general product issue was found.

• 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: 18624388
• Report Number: 1823260-2024-00292
• Device Sequence Number: 7398226
• Product Code: DHR
• UDI-Device Identifier: 04015630927357
• UDI-Public: 04015630927357
• Combination Product (Y/N): Y
• Initial Reporter Country: NO
• 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): 03/04/2024

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: 01/31/2025
• Device Catalogue Number: 05480167190
• Device Lot Number: 705501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2024
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 03/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IL- INHIBITORS.
• Patient Age: 72 YR
• Patient Sex: Male