MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT C-REACTIVE PROTEIN IV; C-REACTIVE PROTEIN TEST SYSTEM

Catalog Number	07876432190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient tested with crpl4 c-reactive protein gen.4 on a cobas c 111 ((b)(4)).No questionable results were reported outside of the laboratory.The sample initially resulted in a crp value of 0.71 mg/l.The sample was repeated twice, resulting in values of 75.85 mg/l and 78.31 mg/l.The 75.85 mg/l value was reported outside of the laboratory.
Additional Manufacturer Narrative
The investigation determined the event was consistent with a preanalytic issue at the customer site.Preanalytics are within the customer's responsibility.There was no indication of a device malfunction.The investigation did not identify a product problem.

• Brand Name: TINA-QUANT C-REACTIVE PROTEIN IV
• 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: 16456974
• Report Number: 1823260-2023-00620
• Device Sequence Number: 12390898
• Product Code: DCN
• UDI-Device Identifier: 04015630946853
• UDI-Public: 04015630946853
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• 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): 03/31/2023

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 Catalogue Number: 07876432190
• Device Lot Number: 64529401
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 03/31/2023
• 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 Age: 8 YR
• Patient Sex: Unknown