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

Catalog Number	08056692190
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	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alb2 reagent expiration was not provided.The ldhi2 reagent lot number was 785535.The expiration was not provided.The cobas c503 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with albumin gen.2 (alb2) assay and ldhi2 assay on cobas c503 analytical unit.This medwatch will apply to the alb2 assay.Please refer to the medwatch with a1 patient identifier (b)(6) for information related to the ldhi2 assay.Alb2: initial result: 1.18 g/dl.Repeat result: 3.63 g/dl.Ldhi2: initial result: 380 u/l.Repeat result: 607 u/l.The physician questioned the initial result of the alb2 as it did not match the patient's clinical picture and the sample was then repeated.
Additional Manufacturer Narrative
The qc for alb2 was within the customer's set ranges.The calibration for alb2 from (b)(6) 2024 to (b)(6) 2024 was acceptable with no alarms.The calibration was last performed on the (b)(6) 2024.The alarm trace on (b)(6) 2024 was acceptable.A hardware check and precision studies were performed and they were within specifications.Based on the information provided, the investigation determined that the event was consistent with a preanalytical handling issue (it is unclear whether a 5- or 10-minute centrifugation program was used).The investigation did not identify a product problem.

• Brand Name: ALB BCG 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: 20311050
• Report Number: 1823260-2024-02789
• Device Sequence Number: 12982613
• Product Code: CIX
• UDI-Device Identifier: 07613336120941
• UDI-Public: 07613336120941
• Combination Product (Y/N): Y
• Initial Reporter Country: CI
• 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): 12/20/2024

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: 08056692190
• Device Lot Number: 786524
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 12/20/2024
• 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