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

Catalog Number	08056714190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pure c 303 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable albumin bcp results from the cobas pure c 303 analytical unit.The initial result was 27g/l.The sample was then sent to another lab as part of the networks iqap and was retested on a cobas c 701 with a result of 37.3 g/l.This result was believed to be correct, and the reported result was amended.An edta sample from the same venipuncture of the patient was teste,d and the result was 40 g/l.
Additional Manufacturer Narrative
The quality control data was acceptable on the day of the event.The analyzer alarm trace did not contain any conspicuous error messages.Analyzer hardware checks were acceptable.Due to the limited information provided, the investigation was unable to determine a specific root cause.There was no product problem identified.

• 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: 22826934
• Report Number: 1823260-2025-02532
• Device Sequence Number: 9567266
• Product Code: CIX
• UDI-Device Identifier: 07613336120958
• UDI-Public: 07613336120958
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/23/2025

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 08056714190
• Device Lot Number: 85129401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 10/23/2025
• 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 Age: 53 YR
• Patient Sex: Female