MAUDE Adverse Event Report: Roche Diagnostics Elecsys HBsAg II Auto Confirm; HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) TEST

Catalog Number	08741034190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable positive results for one patient sample tested with elecsys hbsag ii and elecsys hbsag ii auto confirm on two cobas e 801 analytical unit analyzers.This medwatch will apply to the elecsys hbsag ii auto confirm reagent.Please refer to the medwatch with a1 patient identifier (b)(6) for information related to the elecsys hbsag ii reagent.The sample resulted in hbsag values of 1.3 coi (reactive) and 1.38 coi (reactive) when tested on the e 801 systems.The hbsag auto confirm result was 24 % (reactive) on one of the e 801 systems.The sample was tested with a pcr method and the hbv pcr result was non-reactive.
Additional Manufacturer Narrative
The serial numbers of the e 801 analyzers are (b)(6).It is not known which specific measurements were performed on each analyzer.Calibration and controls were acceptable.A sample from the patient was requested for investigation, but none could be provided.The investigation could not identify a product problem.The cause of the event could not be determined.The reagent performed within specifications.

• Brand Name: Elecsys HBsAg II Auto Confirm
• 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 -045
• 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: 50272181
• Report Number: 1823260-2026-03365
• Device Sequence Number: 16098950
• Product Code: LOM
• UDI-Device Identifier: 07613336172902
• UDI-Public: 07613336172902
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P160019/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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: 08741034190
• Device Lot Number: 898285
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/17/2026
• 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