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

Catalog Number	08056722190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable tina-quant albumin gen.2 assay results for six patient samples tested on the cobas c 503 analytical unit.The following patient samples with discrepant results were identified from the data provided: on (b)(6)2026, the following patient samples were reported: sample 1 initial analysis on the reported cobas c 503 unit yielded a total protein result of 5.50 g/dl.Repeat testing on a secondary c 503 unit yielded 4.20 g/dl.Sample 2 initial testing on the reported c 503 unit yielded 5.54 g/dl, and following instrument maintenance/cleaning, the repeat result was 5.90 g/dl.Repeat testing on the secondary c 503 unit yielded 4.10 g/dl.On (b)(6)2026, the following patient samples were reported: sample 3: initial analysis yielded 6.27 g/dl, with repeat testing yielding 4.77 g/dl.Sample 4: initial analysis yielded 6.01 g/dl, with repeat testing yielding 4.61 g/dl.The customer considers the lower results to be correct, given that the samples were obtained from young and healthy individuals.
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number is (b)(6).

• 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 -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: 50817040
• Report Number: 1823260-2026-03829
• Device Sequence Number: 10680782
• Product Code: DCF
• UDI-Device Identifier: 07613336120965
• UDI-Public: 07613336120965
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• 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): 09/18/2026

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: 08056722190
• Device Lot Number: 94458501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• 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: Unknown