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

Catalog Number	07876424190
Medical Device Problem Codes	Incorrect Measurement (1383); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c 702 analyzer serial number was requested, but not provided.Per product labeling: "in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results." the investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with tina-quant c-reactive protein iv on a cobas 8000 c702 module.The sample initially resulted in a crp value of 350 mg/l.The sample was automatically diluted by the analyzer and repeated, resulting in a value of 571 mg/dl.The dilution factor is unknown.On (b)(6) 2024, the sample resulted in a crp value of 327 mg/l.The sample was tested on an aidian quick read go meter, resulting in a crp value of 77 mg/l.None of the results met the patient's clinical picture as the patient was in good health, in home care.
Additional Manufacturer Narrative
The investigation determined the issue is consistent with sample specific interference (gammopathy).The investigation did not identify a product issue.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21124999
• Report Number: 1823260-2025-00082
• Device Sequence Number: 7436129
• Product Code: DCN
• UDI-Device Identifier: 04015630946846
• UDI-Public: 04015630946846
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 03/04/2025

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: 07876424190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/04/2025
• 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