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

Catalog Number	08056714190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable albumin bcp results from some patient samples tested on the cobas c 503 analytical unit.The results from the analyzer were compared to two competitor analyzers (competitor 1 and competitor 2).Competitor 1's laboratory method is unknown; competitor 2 uses the bromocresol green (bcg) laboratory method.The reporter provided the following examples of questionable results: patient sample 1 the initial result from the analyzer is 29 g/l.The repeat result from competitor 1 is 36 g/l.The repeat result from competitor 2 is 36 g/l.Patient sample 2 the initial result from the analyzer is 28 g/l.The repeat result from competitor 1 is 34 g/l.The repeat result from competitor 2 is 34 g/l.Patient sample 3 the initial result from the analyzer is 41 g/l.The repeat result from competitor 1 is 47 g/l.The repeat result from competitor 2 is 48 g/l.The reporter stated that the different results from the different analyzers make patient care and treatment difficult for doctors.
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number is (b)(6).The investigation included a review of the qc data; the results were within the +/- 2 standard deviation range.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation confirmed that competitor 1 uses the bromocresol green (bcg) laboratory method.The investigation confirmed the higher albumin results obtained by the customer from the competitor's method compared to the albumin bcp.The investigation determined that differences in the specificity of the reaction principles had caused the event.A general reagent issue is unlikely because the qcs are acceptable.The investigation did not identify a product problem.

• 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: 22574524
• Report Number: 1823260-2025-02235
• Device Sequence Number: 21200774
• Product Code: CIX
• UDI-Device Identifier: 07613336120958
• UDI-Public: 07613336120958
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 08/15/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/15/2025
• 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: Unknown