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	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable albumin bcp results for 25 patient samples on a cobas pure c 303 analytical unit.The customer questioned the results as the albumin results were low but the total protein results were normal in patients that do not have kidney disease.Refer to the attachment to the medwatch for all patient data.The units of measurement for total protein were not provided.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The patients' genders, ages, and dates of birth were provided.The data attachment originally reported on 1823260-2026-00302 has been updated with this information.Refer to the attachment to this medwatch.Medwatch fields a2 and a3 have been updated.
Additional Manufacturer Narrative
The calibration and qc recovery data provided was within specification.Based on the calibration and qc data, a general reagent issue could be excluded.The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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: 24199417
• Report Number: 1823260-2026-00302
• Device Sequence Number: 12120286
• 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,Followup
• Report Date (Section B): 04/15/2026

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: 08056714190
• Device Lot Number: 882537
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 01/30/2026; 03/24/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/20/2026; 04/15/2026
• 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 Age: 7 YR
• Patient Sex: Male