MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT ALBUMIN GEN.2 - URINE APPLICATION; ALBUMIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number	04469658190
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
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
There was an allegation of a questionable tina-quant albumin gen.2 - urine application result from the cobas 8000 cobas c 502 module.Patient 1's initial result was 0.7 g/l, the first repeat result was 24.1 g/l, and the second repeat result was 23.1 g/l.Patient 2's initial result was 0.8 g/l, the first repeat result was 48.3 g/l, and the second repeat result was 47.0 g/l.
Additional Manufacturer Narrative
The alarm trace showed frequent calibration flags, and qc recovery indicated that some imprecision remained but was within the required range.A hardware performance check (hpc) was conducted, and the results indicate that sample pipetting was within acceptable limits.The provided data, including the getlog file and alarm traces, did not show any evidence of reagent or instrument-related issues.The root cause was consistent with zero or low pipetting for the two affected samples, possibly due to pre-analytical issues.The investigation determined that no product issue was found.

• Brand Name: TINA-QUANT ALBUMIN GEN.2 - URINE APPLICATION
• Common Device Name: ALBUMIN IMMUNOLOGICAL 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: 22357363
• Report Number: 1823260-2025-01987
• Device Sequence Number: 12747088
• Product Code: DCF
• UDI-Device Identifier: 04015630920587
• UDI-Public: 04015630920587
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101203
• 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): 10/10/2025

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: 11/30/2025
• Device Catalogue Number: 04469658190
• Device Lot Number: 858969
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 10/10/2025
• 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 Age: 38 YR
• Patient Sex: Male