MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT CYSTATIN C GEN.2; CREATININE TEST SYSTEM

Catalog Number	06600263190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c702 module serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with tina-quant cystatin c gen.2 assay on a cobas 8000 c702 module, not matching the patient's clinical diagnosis.Initial result: 8.66 mg/l (accompanied by a data flag).The initial result did not match the patient's clinical diagnosis, prompting the repeat of the sample.No questionable result was reported outside the laboratory.Rerun result: 11.90 mg/l (accompanied by a data flag).
Additional Manufacturer Narrative
Based on the provided information, a reagent or instrument issue can be excluded.The root cause was consistent with an analytical interference by anti-rabbit antibodies.These antibodies bridged the rabbit-derived assay reagents, creating a false-positive signal.The product labeling states: "in very rare cases falsely elevated results for cystatin c will be obtained from samples taken from patients who have been treated with rabbit antibodies or have developed anti-rabbit antibodies." the investigation did not identify a product problem.The cause of the event was consistent with a known interference.

• Brand Name: TINA-QUANT CYSTATIN C GEN.2
• Common Device Name: CREATININE 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23801332
• Report Number: 1823260-2025-05099
• Device Sequence Number: 15792843
• Product Code: NDY
• UDI-Device Identifier: 04015630932405
• UDI-Public: 04015630932405
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161817
• 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): 04/01/2026

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: 03/31/2026
• Device Catalogue Number: 06600263190
• Device Lot Number: 80513501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 04/02/2026
• 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