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

Catalog Number	06600239190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 cobas c 502 module serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable tina-quant cystatin c gen.2 results from six samples from the same patient tested on the cobas 8000 cobas c 502 module.The reporter stated that the patient's results had been steady at 1.3 mg/l in early (b)(6) 2025.Around late (b)(6) 2025, the patient was administered a rabbit-related drug.They suspect that the patient produced rabbit antibodies in mid- (b)(6) 2025 after the drug administration, which interfered with the assay.Please refer to the attachment (b)(6) in the medwatch for the table containing the discrepant results of the six patient samples.
Additional Manufacturer Narrative
The investigation included a review of the data set provided by the customer: several calibrations had flags.The qcs had out-of-range results.The reaction monitors showed an increased absorbance.The investigation noted that the customer used qc as a diluent.Product labeling states, "materials required (but not provided) nacl diluent 9 %.For automatic postdilution and standard serial dilution." the investigation noted that the patient was administered a rabbit-related drug.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.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation determined that the event was consistent with the effect of the rabbit antibodies produced by the patient after drug administration.The investigation did not identify a product problem.

• 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: 22802822
• Report Number: 1823260-2025-02483
• Device Sequence Number: 7797772
• Product Code: NDY
• UDI-Device Identifier: 04015630932399
• UDI-Public: 04015630932399
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 10/03/2025

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: 06600239190
• Device Lot Number: 845176
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/03/2025
• 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: IN ATTACHMENT:(B)(6) CONCOMITANMEDICALPRODUCTS
• Patient Age: 14 YR
• Patient Sex: Male