MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALBUMIN BCP; ALBUMIN BROMCRESOL PURPLE DYE-BINDING METHOD

Catalog Number	08056714190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable albumin bcp results from the cobas pure c 303 analytical unit that did not match the clinical picture.For multiple patient samples, the albumin results were low, but the total protein results were normal without any specific diagnosis related to low albumin results.Two representative examples: example 1: on (b)(6) 2025, the albumin result was 33.80 g/l and the total protein result was 69.9 g/l.Example 2: on (b)(6) 2025, the albumin result was 37.3 g/l and the total protein result was 75.1 g/l.The samples were repeated on another cobas c303 and a cobas c503 analyzers, and the results were identical.The samples were repeated using the "alb-g" assay, and the results were slightly higher but still low.No specific data was provided.
Additional Manufacturer Narrative
The cobas pure c 303 analytical unit serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Based on the data and information provided, a general reagent or hardware related issue was unlikely.Per product labeling for the albumin bcp assay: negative bias of approximately 10 % has been observed on samples from patients undergoing hemodialysis.The investigation determined that the event was consistent with issues with the specific patient samples.There was no indication of a device malfunction.

• Brand Name: ALBUMIN BCP
• Common Device Name: ALBUMIN BROMCRESOL PURPLE DYE-BINDING METHOD
• 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: 23593030
• Report Number: 1823260-2025-04699
• Device Sequence Number: 10256428
• Product Code: CIX
• UDI-Device Identifier: 07613336120958
• UDI-Public: 07613336120958
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K844426
• 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): 12/29/2025

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: 08056714190
• Device Lot Number: 86330301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/29/2025
• 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: Male