MAUDE Adverse Event Report: Roche Diagnostics Elecsys HBsAg II; Test, Hepatitis B

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	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable results with the elecsys hbsag ii assay for a donor sample tested on the roche instrument (details have been requested).It was reported that the patient has always been non-reactive on a non-roche instrument.Since switching to roche instruments, the last two times the patient has been reactive for hbsag but then confirmed negative for hbsag.The test was repeated as the reactive result did not match previous history.
Additional Manufacturer Narrative
The analyzer information was requested.The investigation is ongoing.

• Brand Name: Elecsys HBsAg II
• Common Device Name: Test, Hepatitis B
• 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: 50870259
• Report Number: 1823260-2026-03906
• Device Sequence Number: 18820402
• Product Code: LOM
• UDI-Device Identifier: 07613336183076
• UDI-Public: 07613336183076
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P160019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 08814848162
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/23/2026
• 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 Age: 60 YR
• Patient Sex: Male