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

Catalog Number	08105596190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c503 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 3 patients' samples tested with tina-quant cystatin c gen.2 (cysc2) assay on a cobas c503 analytical unit.Sample 1 (patient (b)(6): initial result: 3.38 mg/l.Repeat result: 1.26 (when tested on alinity).Sample 2 (patient (b)(6): initial result: 7.82 mg/l.Repeat result: 2.04 (when tested on alinity).The physician questioned the initial results and requested that sample 1 and sample 2 be repeated.The unit of measurement for the repeat results was not provided.It was confirmed that sample 1 and sample 2 contained m-component type: igm.Sample 3 (patient (b)(6) was tested on (b)(6) 2025: initial result: 3.19 mg/l.1st repeat result: 2.02 mg/l.2nd and 3rd repeat results were 1.76 mg/l and 1.56 mg/l (both accompanied by data flags).
Additional Manufacturer Narrative
Correction: sample 3 (patient 3) was a 2nd sample for patient 1 and not a 3rd patient.The customer alleged discrepant results for an additional patient: patient 3 was tested on (b)(6) 2025 and had polyclonal immunoglobulins: initial result: 6.92 mg/l (accompanied by a data flag).Repeat results: 5.30 mg/l (tested using decreased sample volume).2.64 mg/l (tested with a dilution factor of 1:3).1.92 mg/l (tested with a dilution factor of 1:5 and accompanied by a data flag).1.39 mg/l (tested with a dilution factor of 1:10 and accompanied by a data flag).1.57 mg/l (tested with a dilution factor of 1:20 and accompanied by a data flag).The results with the undiluted and diluted samples indicated an interference in the samples for the 3 patients, like gammopathy and/or rabbit antibodies.The product labeling states: "in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results.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 did not identify a product problem.The product meets the specifications.The cause of the event was due to interference in the samples.
Additional Manufacturer Narrative
Section b7 was updated.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21949562
• Report Number: 1823260-2025-01365
• Device Sequence Number: 15543373
• Product Code: NDY
• UDI-Device Identifier: 07613336133644
• UDI-Public: 07613336133644
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,Followup
• Report Date (Section B): 07/25/2025

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 08105596190
• Device Lot Number: 80513601
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 05/06/2025; 06/30/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/30/2025; 07/25/2025
• 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
• Patient Sex: Unknown