MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT C-REACTIVE PROTEIN IV; C-REACTIVE PROTEIN TEST SYSTEM

Catalog Number	08057591190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable tina-quant c-reactive protein iv results for 1 patient sample on a cobas c 503 analytical unit.The initial result was 16.3 mg/l.The initial result was questioned, and the physician requested that the sample be repeated.The repeated results were 71.5 mg/l and 74.7 mg/l.The result of 74.7 mg/l was believed to be correct based on the patient's clinical history.
Additional Manufacturer Narrative
The calibration and qc were acceptable.A general reagent issue was excluded.Due to the lack of information provided, the investigation could not determine the exact cause of the event.The investigation did not identify a product problem.

• Brand Name: TINA-QUANT C-REACTIVE PROTEIN IV
• Common Device Name: C-REACTIVE PROTEIN 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22481862
• Report Number: 1823260-2025-02125
• Device Sequence Number: 8554929
• Product Code: DCN
• UDI-Device Identifier: 07613336121191
• UDI-Public: 07613336121191
• Combination Product (Y/N): N
• Initial Reporter Country: BA
• PMA/510(K) Number: K192072
• 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): 10/03/2025

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: 08057591190
• Device Lot Number: 864933
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 10/03/2025
• 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