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

Model Number	CRP G4
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided for investigation.The investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for tina-quant c-reactive protein iv (crp4) on a cobas 6000 c (501) module.The initial result was 71.9 mg/l.The sample was repeated from the primary tube with a result of 244 mg/l.The sample was repeated from a cup with a result of 253 mg/l.It is not known if the questionable result was reported outside of the laboratory.The c501 module serial number was (b)(4).

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16888154
• Report Number: 1823260-2023-01535
• Device Sequence Number: 20356443
• Product Code: DCN
• UDI-Device Identifier: 04015630946839
• UDI-Public: 04015630946839
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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
• Report Date (Section B): 05/08/2023

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 Model Number: CRP G4
• Device Catalogue Number: 07876033190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/08/2023
• 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