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 Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable elecsys hbsag ii auto confirm result from the cobas e 801 analytical unit.The initial result was 1.36 coi (positive), and the repeat result was 1.22 coi (positive).An auto confirmation test result was 37% and confirmed to be reactive.Due to the patient's history the doctor requested a new sample from the patient.On (b)(6) 2025, on the same cobas pro the results of the hbsag and the auto confonfirmation, were both reactive.They were then tested on abbott analyzers and the results were negative.On (b)(6) 2025, both the first and second samples were aliquoted and sent to two separate labs, both using e 801 analyzers and the results were negative, with results around 0.6 coi for both samples.One of the labs also performed auto confonfirmation testing, with indeterminate results for both samples.The samples were both repeated on (b)(6) 2025.The first samples hbsag result was 0.633 coi (non-reactive), hbsag2cl: 58% (indeterminate) the second samples hbsag result was 0.75 coi (non-reactive), hbsag2cl: 60.3%.(confirmation not valid).
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).It was noted that both positive samples were processed using the primary tubes, while the samples that were sent out and repeated were from secondary tubes.Qc passed prior to the event.The investigation is ongoing.
Additional Manufacturer Narrative
There was no sample available for investigation.According to the method sheet, if the hbsag confirmatory results are indeterminate or a non-valid result is given, it should be repeated.If the results are the same, a follow-up sample should be measured.

• 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: 22468900
• Report Number: 1823260-2025-02103
• Device Sequence Number: 11788855
• Product Code: LOM
• UDI-Device Identifier: 07613336172902
• UDI-Public: 07613336172902
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: P160019/S014
• 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,Followup
• Report Date (Section B): 07/30/2025

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: 820221
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 07/30/2025
• 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