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	Incorrect, Inadequate or Imprecise Result or Readings (1535); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged that one patient sample tested reactive for hbsag g2 confirmatory elecsys e2g on the cobas pure e 402 analytical unit.The result was confirmed using the hbsag ii confirmatory assay.Additionally, the sample tested positive for anti-hbs and anti-hbc.
Additional Manufacturer Narrative
The reported event occurred on a cobas e 402 analyzer (serial number: (b)(6).The investigation was limited due to the unavailability of calibration data, quality control data, and patient sample material.A definitive root cause for the reported event could not be determined based on the available information.The case was closed, and no further action could be taken.Additional investigation may be conducted if further information or sample material becomes available.

• 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: 23065051
• Report Number: 1823260-2025-02921
• Device Sequence Number: 10044335
• Product Code: LOM
• UDI-Device Identifier: 07613336172902
• UDI-Public: 07613336172902
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P160019/S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/16/2025

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 Catalogue Number: 08741034190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 09/16/2025
• 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