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

Catalog Number	08057591190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation reviewed the system's alarm trace and a high amount of abnormal aspiration alarms were found, which are indicators of possible preanalytical handling issues.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable tina-quant c-reactive protein iv results for 1 patient sample on a cobas c 303 analytical unit.The initial result was 362 mg/l (with a data flag).The sample was automatically diluted and the result was 34.9 mg/l.The sample was repeated and the result was 366 (with a data flag).The sample was automatically diluted and the result was 392 mg/l.
Additional Manufacturer Narrative
The qc data demonstrated imprecision.The field service representative checked and replaced the sample probe.No improvements were observed.The investigation reviewed the preanalytic's and found that 5 ml bd advanced sst ii tubes with separation gel were used and the centrifugation time is only 5 minutes at 2880 g, which is likely insufficient.The issue is consistent with inadequate preanalytical handling.No general product issue was found, the product meets specification.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19019182
• Report Number: 1823260-2024-00993
• Device Sequence Number: 18185722
• Product Code: DCN
• UDI-Device Identifier: 07613336121191
• UDI-Public: 07613336121191
• Combination Product (Y/N): Y
• Initial Reporter Country: EZ
• 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): 05/10/2024

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: 08057591190
• Device Lot Number: 750270
• 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: 03/06/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/10/2024
• 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