MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HBSAG II; HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) TEST

Catalog Number	08814848162
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of false-positive elecsys hbsag ii results for 1 patient sample on a cobas e 801 analytical unit.The initial result was 1.02 coi (reactive).The sample was repeated, and the results were 1.01 coi (reactive) and 0.998 coi (reactive).On (b)(6) 2025, confirmatory testing confirmed that the sample was non-reactive.A new sample was obtained from the patient, and the elecsys hbsag ii result was non-reactive.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The qc and calibration were acceptable.A general reagent issue was excluded.The field service representative verified alignments, performed checks with acceptable results, and performed tests with acceptable results.No abnormalities were found.The investigation did not identify a product problem.

• Brand Name: ELECSYS HBSAG II
• Common Device Name: HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) TEST
• 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: 23570375
• Report Number: 1823260-2025-04667
• Device Sequence Number: 16020490
• Product Code: LOM
• UDI-Device Identifier: 07613336183076
• UDI-Public: 07613336183076
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160019
• 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): 12/22/2025

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 08814848162
• Device Lot Number: 835064
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/22/2025
• 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