MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CRP4; C REACTIVE PROTEIN TEST SYSTEM

Catalog Number	07876033190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of a discrepant low result for 1 patient sample tested for crp4 on a cobas 6000 c501 module.The initial result was 3.69 mg/l.This result was reported outside of the laboratory.As the patient had a crp4 result of 179.8 mg/l two days before, the sample was repeated.The sample was repeated twice with results of 80.25 mg/l and 79.3 mg/l.
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).
Additional Manufacturer Narrative
The customer did not provide any additional information.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: CRP4
• 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: 18573007
• Report Number: 1823260-2024-00217
• Device Sequence Number: 7780426
• Product Code: DCN
• UDI-Device Identifier: 04015630946839
• UDI-Public: 04015630946839
• Combination Product (Y/N): Y
• Initial Reporter Country: TC
• 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): 02/09/2024

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 Expiration Date: 06/30/2024
• Device Catalogue Number: 07876033190
• Device Lot Number: 7342234
• 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: 01/02/2024
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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