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

Catalog Number	05480167190
Medical Device Problem Codes	Low Test Results (2458); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon review of the alarm trace, there were frequent errors indicating canceled tests, incomplete calibrations, and short sample.Abnormal aspiration errors were also observed.Calibration data was acceptable.The quality control data showed an outside of range low result.A general issue with the software and hardware can be excluded.There was no information suggesting the patient sample contains an interferent.The investigation determined the issue is consistent with incorrect user handling of automatic dilutions.
Additional Manufacturer Narrative
The c 702 analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with rheumatoid factors ii rf-ii on a cobas 8000 c702 module.The customer alleged the analyzer was not performing automatic dilutions as expected.The sample initially resulted in a rheumatoid factor value of 98 iu/ml.The sample was then automatically diluted 1:20 and repeated, resulting in a value of > 650 iu/ml.The sample was repeated on 24-oct-2024, resulting in a rheumatoid factor value of 104 iu/ml.The sample automatically repeated at a decreased sample volume on (b)(6) 2024, resulting in a value of 549 iu/ml.The sample was repeated two additional times on (b)(6)2024, resulting in values of 101 iu/ml and 101 iu/ml.The sample was repeated on 25-oct-2024, resulting in a rheumatoid factor value of 106 iu/ml.The sample was repeated on 29-oct-2024, resulting in a rheumatoid factor value of 109 iu/ml.

• 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: 20749508
• Report Number: 1823260-2024-03387
• Device Sequence Number: 12855044
• Product Code: DHR
• UDI-Device Identifier: 04015630927357
• UDI-Public: 04015630927357
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 12/13/2024

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 Catalogue Number: 05480167190
• Device Lot Number: 782678
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/13/2024
• 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