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

Model Number	C701
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	04/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 3 patients' samples tested with albumin (alb2) assay on a cobas 8000 cobas c701 module.Discrepant result for one sample was provided and the patient's sample was a plasma sample.Initial result: 2.93 g/dl.Repeat result: 3.45 g/dl.The questionable result was reported outside the laboratory.Qc had dropped out by 3sd prompting the rerun of the sample.The rerun result was deemed to be correct.A report with the corrected results for the 3 samples was reported outside the laboratory.The alb2 reagent lot number was 67564801 with an expiration date of 29-feb-2024.
Additional Manufacturer Narrative
The field service engineer (fse) replaced the reagents mixers, the degasser tank and the water bath degasser.The fse did service diagnostics check and it was acceptable.Qc was performed and was acceptable.Investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.The service actions (replacing the reagents mixers, the degasser tank and the water bath degasser) resolved the issue.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16975586
• Report Number: 1823260-2023-01705
• Device Sequence Number: 6608367
• Product Code: CIX
• UDI-Device Identifier: 04015630924820
• UDI-Public: 04015630924820
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023
• 2 Devices were Involved in the Event: 1 2

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: 02/29/2024
• Device Model Number: C701
• Device Catalogue Number: 05166861190
• Device Lot Number: 67564801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male