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

Catalog Number	11820648122
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas e 801 analyzer with serial number (b)(6).The investigation determined that the elecsys hbsag confirmatory test reagent performed within specifications.A review of calibration and quality control data confirmed that all results were within expected ranges.The investigation was limited due to the unavailability of sufficient patient sample material for further analysis.The root cause was attributed to a sample-specific discrepancy.Further testing for hbsag is recommended for this patient.For diagnostic purposes, results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.
Event or Problem Description
The initial reporter alleged discrepant reactive results for one patient sample tested with the elecsys hbsag ii assay and the elecsys hbsag confirmatory test on a cobas e 801 analytical unit.On (b)(6) 2022, the elecsys hbsag ii assay generated a result of 1.51 coi (reactive), and the elecsys hbsag confirmatory test also generated a reactive result.Additional testing on the same sample using the elecsys anti-hbs (ahbs) assay produced a result of 2.0 iu/l (non-reactive).Testing of different blood draws from the same patient was conducted on (b)(6) 2022 using competitor systems (abbott and siemens).Both systems reported non-reactive results for hbsag and ahbs.No further result details were provided for these tests.

• Brand Name: ELECSYS HBSAG II CONFIRMATORY TEST
• Common Device Name: TEST, HEPATITIS B (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: 23073717
• Report Number: 1823260-2025-02996
• Device Sequence Number: 9996714
• Product Code: LOM
• UDI-Device Identifier: 04015630911110
• UDI-Public: 04015630911110
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P160019/S010
• 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
• Report Date (Section B): 09/17/2025

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: 06/30/2023
• Device Catalogue Number: 11820648122
• Device Lot Number: 582537
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 09/17/2025
• 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