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

Catalog Number	08814848190
Medical Device Problem Codes	False Positive Result (1227); Non Reproducible Results (4029)
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
The initial reporter questioned a positive result for 1 patient sample tested for elecsys hbsag ii (hbsag ii) on a cobas e 801 analytical unit.The initial result was 4.97 coi (positive).The repeat results were 0.338 coi (negative) and 0.365 coi (negative).The sample was repeated, and the result was 0.359 coi (negative).The sample was repeated on the customer¿s other cobas pro analyzer, and the results were 0.399 coi (negative) and 0.326 coi (negative).
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).

• 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: 50857207
• Report Number: 1823260-2026-03888
• Device Sequence Number: 9553518
• Product Code: LOM
• UDI-Device Identifier: 07613336168103
• UDI-Public: 07613336168103
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• PMA/510(K) Number: P160019
• 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): 09/22/2026

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: 863553
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/22/2026
• 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