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

Catalog Number	07876033190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
Medwatch field h6 coding has been updated.
Additional Manufacturer Narrative
The serial number of the c501 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they have received implausibly low results for one newborn patient tested with tina-quant c-reactive protein iv on a cobas 6000 c501 module.The customer and several clinicians allege that the crp results are implausibly low compared to high il-6 values.On (b)(6) 2025, the patient had a crp value of < 0.6 mg/l and an il-6 value of 302 ng/l.On (b)(6) 2025, the patient had a crp value of < 0.6 mg/l and an il-6-ngb value of 397 ng/l.On (b)(6) 2025, the patient had a crp value of 1.0 mg/l and an il-6 value of 258 ng/l.

• 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: 23424134
• Report Number: 1823260-2025-04422
• Device Sequence Number: 18206185
• Product Code: DCN
• UDI-Device Identifier: 04015630946839
• UDI-Public: 04015630946839
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 12/22/2025

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: 07876033190
• Device Lot Number: ASKU
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 11/27/2025; 12/16/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/15/2025; 12/22/2025
• 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