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

Catalog Number	04469658190
Medical Device Problem Codes	Low Test Results (2458); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number was 845956.The expiration date was requested, but not provided.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable albt2 tina-quant albumin gen.2 for urine samples from one patient using a cobas 8000 cobas c 502 module.The initial result was <12 mg/l with a data flag.The first repeat result was 143 mg/l.The second and third repeat results were 44 mg/l and 83 mg/l.The first repeat result was questioned as it was considered too high which triggered the further repeat testing of the sample.None of the results were reported out.It is unknown which results were deemed correct.
Additional Manufacturer Narrative
The field service engineer (fse) checked the pump pressure, water pump, gear pump, and valves.All were operating with no issues.The fse performed successful calibration, hardware checks, and precision.The instrument performance was verified.No further issues were reported since the service visit.The investigation did not identify a product problem.The exact root cause could not be determined.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• 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 46250-0457
• MDR Report Key: 22563902
• Report Number: 1823260-2025-02231
• Device Sequence Number: 3993784
• Product Code: DCF
• UDI-Device Identifier: 04015630920587
• UDI-Public: 04015630920587
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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: 04469658190
• Device Lot Number: 845956
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/14/2025
• 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: 67 YR
• Patient Sex: Male