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 Codes	Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter establishment name: (b)(6) hospital.The analyzer's serial number is (b)(6).The calibration was acceptable.The sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys hbsag ii auto confirm results for 1 patient sample on a cobas e 801 analytical unit.The sample was invalid with the elecsys hbsag ii auto confirm.It was alleged that the sample's elecsys hbsag ii results were repeatedly reactive.The sample's elecsys hbsag ii results were 0.97 coi, 1.03 coi, and 0.47 coi.The hbsag confirmation test is used to verify the hbsag results.

• 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 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: 24536401
• Report Number: 1823260-2026-00802
• Device Sequence Number: 13376596
• Product Code: LOM
• UDI-Device Identifier: 07613336172902
• UDI-Public: 07613336172902
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P160019/S014
• 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): 05/13/2026

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: 85289701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 05/13/2026
• 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