MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE; CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL

Catalog Number	08057605190
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	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number is (b)(6).The customer noted that the sample gave high igm results of 37.5 mg/l.The customer suspects interference due to this information.A sample was not available for investigation; therefore, it was not possible to define the root cause.
Event or Problem Description
There was an allegation of a questionable cardiac c-reactive protein (latex) high sensitive result from the cobas c 503 analytical unit.The initial result was 76 mg/l, accompanied by a data flag.When run on decreased sample volume mode, and the result was 0.000 mg/l, accompanied by a data flag.Manual dilutions of 1:5, 1:10, and 1:20 were completed, and the results were 0.000 mg/l, accompanied by a data flag.They tried to warm the sample and still received a result of 76 mg/l, accompanied by a data flag.They ran the sample on crp4 and received a result of 8.68 mg/l.

• Brand Name: CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE
• Common Device Name: CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL
• 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: 22674630
• Report Number: 1823260-2025-02359
• Device Sequence Number: 7495802
• Product Code: NQD
• UDI-Device Identifier: 07613336121207
• UDI-Public: 07613336121207
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K053603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 08057605190
• Device Lot Number: 782382
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/31/2025
• 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