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

Catalog Number	05167043190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The albt2 reagent expiration date was not provided.The c702 module serial number was (b)(6).The customer was having qc issues.The field service engineer replaced the rinse tubes, checked the needle alignment, the gear pump, the needle washing, and the washing station dispensing.He then performed some checks, including qc and changing the reagent trays, but the issue persisted.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with tina-quantalbumin gen.2 (albt2) assay on a cobas 8000 c702 module.Sample 1: the results ranged from 2.8 g/dl to 3.4 g/dl.The sample was repeated on a different cobas analyzer, resulting in the same value range.Sample 2: the results ranged from 3 g/dl to 3.6 g/dl.The sample was repeated on a different cobas analyzer, resulting in the same value range.No exact values were provided.The results' range was from 0.6 g/dl to 0.7 g/dl.
Additional Manufacturer Narrative
No general product issue was found.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: TINA-QUANTALBUMIN 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: 22817377
• Report Number: 1823260-2025-02515
• Device Sequence Number: 9014200
• Product Code: DCF
• UDI-Device Identifier: 04015630924899
• UDI-Public: 04015630924899
• 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): 09/15/2025

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: 05167043190
• Device Lot Number: 836567
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/15/2025
• 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