MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HBSAG II; TEST, HEPATITIS B

Catalog Number	08814848190
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hbsag ii reagent expiration date was not provided.The cobas e 801 analytical unit serial number was (b)(6).The data was requested to carry out the investigation but was not provided.The investigation did not identify a product problem.
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with elecsys hbsag ii assay on a cobas e 801 analytical unit.For quantitative test only: this device (hbsag quantitative) or a similar device (hbsag quantitative) is not cleared or approved for use in the us.Sample 1: the qualitative test result was 0.312 coi.The quantitative test result was 0.168 iu/ml.Sample 2 was on (b)(6) 2026: the qualitative test results were 1.16 coi and 0.448 coi.The quantitative test result was 92.4 iu/ml.Sample 1 and sample 2 were repeated for the qualitative test, and the repeat results were both negative and consistent with the patients' previous negative history for hepatitis b virus (hbv).

• Brand Name: ELECSYS HBSAG II
• Common Device Name: TEST, HEPATITIS B
• 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: 25058361
• Report Number: 1823260-2026-01715
• Device Sequence Number: 15777898
• Product Code: LOM
• UDI-Device Identifier: 07613336168103
• UDI-Public: 07613336168103
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P160019/S010
• 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): 06/05/2026

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: 08814848190
• Device Lot Number: 90551700
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 06/05/2026
• 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