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

Catalog Number	03183688122
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c502 analyzer serial number was (b)(6).The root cause was environmental.Investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 20 patients' samples tested with albumin (alb2) assay on a cobas 8000 cobas c502 analyzer.The customer stated that the results for the 20 patients' sample were less than 3 g/dl while their previous results were close to 5 g/dl.Discrepant results for 2 patients' samples were provided.Sample 1: initial result: 2.44 g/dl.Repeat result: 4.3 g/dl.Sample 2: initial result: 2.66 g/dl.Repeat result: 4.56 g/dl.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
The field service engineer (fse) performed full decontamination and built special wash settings.The fse increased the repeated limit of alb samples from 3.7 g/dl to 6.0 g/dl, which will repeat every alb sample that goes through the analyzer.He also adjusted the centrifuge speed and the spin time.The fse did operational and/or mechanical checks and the instrument was performing within specifications.Qc was performed and it was acceptable.The root cause was due to an environmental issue.The service actions done resolved the issue.No further issues were reported afterward.

• 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: 17719453
• Report Number: 1823260-2023-02941
• Device Sequence Number: 15240889
• Product Code: CIX
• UDI-Device Identifier: 04015630918898
• UDI-Public: 04015630918898
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 11/10/2023

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: 03183688122
• Device Lot Number: ASKU
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 11/10/2023
• 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: Unknown