MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALB2 ALBUMIN GEN.2; BROMCRESOL GREEN DYE-BINDING, ALBUMIN

Catalog Number	05166861190
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	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).Calibration and qc data were acceptable.A review of the alarm trace showed few abnormal aspiration alarms present on the day of the event.Investigation is ongoing.
Event or Problem Description
There was an allegation of questionable albumin gen.2 assay results for two patient samples on a cobas 8000 c702 module.Both samples were repeated as the results did not match the patient's history.Sample 1: the initial result was < 2 g/l.The repeated result was 51.5 g/l.Sample 2: the initial result was < 2 g/l.The repeated result was 44 g/l.None of the results were reported out.
Additional Manufacturer Narrative
A general reagent issue was excluded as calibration and qc data were acceptable.The analyzer alarm trace contained sample handling-related alarms which indicate a preanalytical issue in the lab.The investigation determined the issue was consistent with pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.The investigation did not identify a product problem.

• Brand Name: ALB2 ALBUMIN GEN.2
• Common Device Name: BROMCRESOL GREEN 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20856508
• Report Number: 1823260-2024-03534
• Device Sequence Number: 8865184
• Product Code: CIX
• UDI-Device Identifier: 04015630924820
• UDI-Public: 04015630924820
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033009
• 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): 01/03/2025

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: 05166861190
• Device Lot Number: 804903, 814915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/03/2025
• 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