MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CRPHS; CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL

Catalog Number	04628918190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable crp lx hs result from the cobas 8000 cobas c 502 module.The initial result was 63.55 mg/l with a data flag.The 1:15 auto-diluted result was 10.8 mg/l.The repeat result with a 1:3 dilution was 65.89 mg/l with a data flag.The 1:15 auto-diluted result was 10.3 mg/l.The result using a 1:5 dilution was 45.64 mg/l.The result using a 1:10 dilution was 15.38 mg/l.The results were not reported outside of the laboratory.The customer did not know which result was correct.
Additional Manufacturer Narrative
The cobas 8000 cobas c 502 module serial number was 18m6-10.The customer declined a service visit.The investigation was unable to determine a specific root cause based on the limited information.A sample-specific issue such as a possible interfering substance in the sample could not ruled out.

• Brand Name: CRPHS
• 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: 18173411
• Report Number: 1823260-2023-03696
• Device Sequence Number: 12665063
• Product Code: NQD
• UDI-Device Identifier: 04015630921508
• UDI-Public: 04015630921508
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2023

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: 09/30/2024
• Device Catalogue Number: 04628918190
• Device Lot Number: 69280601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 11/20/2023
• 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