MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HBC II; HEPATITIS B TEST (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number	07374160160
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas e 602 analyzer ((b)(6)).The investigation determined that the elecsys anti-hbc ii assay performed within specifications.A review of quality control, calibration, and alarm data did not identify any issues.However, the investigation was limited as no sample material was available for further analysis.The negative percent agreement for the elecsys anti-hbc ii assay with non-hbv-infected status was 98.4% (601/611) with a 95% confidence interval of 97.0¿99.2%, indicating that false positive results can occur.A definitive conclusion regarding the discrepant results could not be determined due to insufficient information about the assay used at labcorp.
Event or Problem Description
The initial reporter alleged discrepant reactive results with the anti-hbc g2 elecsys assay on the cobas 8000 - cobas e 602 module when compared to results from a competitor assay.On (b)(6)2019, the sample was initially tested on a cobas e 801 analyzer and generated a result of 0.559 coi (reactive).On (b)(6)2019, the same sample was tested at quest diagnostics and resulted as non-reactive.On (b)(6)2019, the sample was re-tested on both the cobas e 602 module and the cobas e 801 analyzer, with both systems generating reactive results.On (b)(6)2019, the sample was tested at labcorp and resulted as non-reactive.

• Brand Name: ELECSYS ANTI-HBC II
• Common Device Name: HEPATITIS B TEST (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• 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: 23064144
• Report Number: 1823260-2025-02909
• Device Sequence Number: 18653112
• Product Code: LOM
• UDI-Device Identifier: 07613336142295
• UDI-Public: 07613336142295
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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 Expiration Date: 01/31/2020
• Device Catalogue Number: 07374160160
• Device Lot Number: 38761000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2019
• 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