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

Catalog Number	05599261190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.Based on the available data, a general reagent issue could be excluded.The field service engineer (fse) found that the ball bearings of the sample pipettor were worn and replaced it.The service maintenance actions performed by the fse resolved the issue.
Event or Problem Description
There was an allegation of questionable albumin bcp results for 1 patient sample on a cobas 6000 c501 module.The doctor questioned the low initial result which prompted the customer to repeat the sample.The initial result was 1167 mg/dl.The repeat result was 4331 mg/dl.

• Brand Name: ALBUMIN BCP
• Common Device Name: BROMCRESOL PURPLE DYE-BINDING, ALBUMIN
• 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: 23359666
• Report Number: 1823260-2025-04294
• Device Sequence Number: 8871635
• Product Code: CJW
• UDI-Device Identifier: 04015630927562
• UDI-Public: 04015630927562
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K844426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/22/2025

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: 05599261190
• Device Lot Number: 788349
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 10/22/2025
• 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