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

Catalog Number	08056722190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter questioned the result for 1 patient urine sample tested for tina-quant albumin gen.2 (albt2) total protein urine/csf gen.3 (tpuc3) on a cobas c 503 analytical unit.The 24-hour albt2 result was reportedly 924 mg/l (result not multiplied by the total diuresis).The 24-hour total protein result was reportedly 284 mg/l (when multiplied by the total 24-hour diuresis volume of 3500 ml, the result was 994 mg).The albt2 result is outside the test's measurement range of 3 ¿ 400 mg/l.It was noted that the tests were accompanied by >test flags; however, the measurement range for total protein is 40 ¿ 2000 mg/l.Clarification on the results and unit of measure has been requested but has not been provided.The nephrologist questioned the albt2 result as the result should be equal to or less than the total protein result.
Additional Manufacturer Narrative
The customer did not provide any additional information.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: TINA-QUANT ALBUMIN GEN.2
• 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: 22563822
• Report Number: 1823260-2025-02225
• Device Sequence Number: 21168967
• Product Code: DCF
• UDI-Device Identifier: 07613336120965
• UDI-Public: 07613336120965
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 08/25/2025

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 Catalogue Number: 08056722190
• Device Lot Number: 858773
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/25/2025
• 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