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

Catalog Number	07876424190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable tina-quant c-reactive protein iv results from five samples from the same patient tested on the cobas 8000 c702 module.The results were questioned as they did not fit the patient's clinical picture.On (b)(6) 2024, the result was >700 mg/l with a data flag.On (b)(6) 2024, the result was >700 mg/l with a data flag.On (b)(6) 2024, the result was >700 mg/l with a data flag.On (b)(6) 2024, the result was >700 mg/l with a data flag.On (b)(6) 2024, the result at 1:2 dilution was >700 mg/l with a data flag.The patient sample from (b)(6) 2024 was sent to another laboratory that uses an abbott analyzer.The result from this analyzer was 85 mg/l with a data flag.The result of the linearity study using serial dilution did not produce linear results and suggested an interferent in the patient sample.
Additional Manufacturer Narrative
The serial number of the customer's cobas 8000 c702 module is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The customer's current calibration results are flagged.The customer's qc recovery showed high imprecision.The patient sample was received for investigation and was tested for crp4 in normal, decreased mode and 1:10 automatic dilution.The investigation's qc recovery was within the specified ranges.The investigation confirmed the customer's results.A reagent-specific issue was not identified.The reagent is working according to specifications.The investigation determined the event was consistent with a patient-sample issue (interference or gammopathy).Based on the information provided, the event's specific cause could not be determined.

• 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: 20787439
• Report Number: 1823260-2024-03438
• Device Sequence Number: 7895160
• Product Code: DCN
• UDI-Device Identifier: 04015630946846
• UDI-Public: 04015630946846
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/17/2025

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: 07876424190
• Device Lot Number: 813726
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: 02/09/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 02/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: REFER TO THE ATTACHMENT PT-0072513 IN THE MEDWATCH.
• Patient Age: 46 YR
• Patient Sex: Male