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

Catalog Number	04628918190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The crphs reagent expiration date was not provided.The cobas integra 400 plus analyzer serial number was (b)(6).The qc was within range.The exchange of both probes, the maintenance of the wash stations, and the cleaning of the internal water reservoir were last performed in (b)(6) 2024.The investigation is ongoing.
Event or Problem Description
We received an allegation of a high result not corresponding to the clinical picture for 1 patient serum sample tested with cardiac c-reactive protein (latex) high sensitive (crphs) assay on a cobas integra 400 plus analyzer.Initial result: 1146.2 mg/l.The physician questioned the initial result as it was high and did not correspond to the patient's clinical picture.The physician also requested a repeat of the sample.1st repeat result: 1171.5 mg/l.2nd repeat result: 114.5 mg/l (tested with 1:15 dilution).3rd repeat result: 116.1 mg/l (tested with 1:15 dilution).The 2nd and 3rd repeat results corresponded to the patient's clinical picture.
Additional Manufacturer Narrative
The result of 1146.2 mg/l was accompanied by a data flag and tested with 1:15 dilution.The result of 1171.5 mg/l was accompanied by a data flag and tested with 1:15 dilution.The investigation did not identify a product problem.The product meets the specifications.The cause of the event was due to a user-handling error where the wrong assay was used (the primary measuring range exceeded 5 times).The cause was also consistent with a sample quality issue and cup configuration.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20864455
• Report Number: 1823260-2024-03554
• Device Sequence Number: 12935124
• Product Code: NQD
• UDI-Device Identifier: 04015630921508
• UDI-Public: 04015630921508
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K053603
• 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): 12/16/2024

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: 04628918190
• Device Lot Number: 79281601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 12/16/2024
• 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