MAUDE Adverse Event Report: Roche Diagnostics Tina-quantAlbumin Gen.2; Albumin immunological test system

Catalog Number	05167043190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable tina-quant albumin gen.2 results for 1 patient sample on a cobas 8000 cobas c 701 module.Initial result: 80.7 mg/l the sample was repeated on another module, and the results were 27.8 mg/l and 27.8 mg/l.The sample was repeated on the same module as the initial result, and the result was 31.2 mg/l.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The field service representative washed the probe.The investigation is ongoing.

• Brand Name: Tina-quantAlbumin Gen.2
• Common Device Name: Albumin immunological test system
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50792415
• Report Number: 1823260-2026-03786
• Device Sequence Number: 21186077
• Product Code: DCF
• UDI-Device Identifier: 04015630924899
• UDI-Public: 04015630924899
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 95360301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/16/2026
• 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: Female