MAUDE Adverse Event Report: Roche Diagnostics Albumin Gen.2; BROMCRESOL GREEN DYE-BINDING, ALBUMIN

Catalog Number	08056692190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of a discrepant low result for 1 patient sample tested for albumin gen.2 (alb2) on a cobas c 303 analytical unit.The initial result was 4.15 g/dl.The repeat result was 0.458 g/dl.The repeat result was reported outside of the laboratory, where it was questioned by the physician, as it was inconsistent with the patient¿s total protein result and clinical presentation.The initial result was believed to be correct.
Additional Manufacturer Narrative
The c303 analyzer serial number was (b)(6).

• Brand Name: Albumin Gen.2
• Common Device Name: BROMCRESOL GREEN DYE-BINDING, ALBUMIN
• 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: 50858825
• Report Number: 1823260-2026-03892
• Device Sequence Number: 13138773
• Product Code: CIX
• UDI-Device Identifier: 07613336120941
• UDI-Public: 07613336120941
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K033009
• 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): 09/22/2026

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: 08056692190
• Device Lot Number: 95309801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/22/2026
• 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