MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HBSAG II; TEST, HEPATITIS B

Catalog Number	08814848162
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The elecsys hiv duo results were obtained on a cobas e 801 analytical unit with serial number (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys hbsag ii and elecsys hiv duo results for 1 patient on a cobas e 801 analytical unit.The initial elecsys hiv duo result was reactive.On (b)(6) 2026, the sample was sent for confirmatory testing.The confirmatory hiv (genius method) test result was "confirmed non-reactive".The initial elecsys hbsag ii result was reactive.On(b)(6) 2026, the sample was sent for confirmatory testing.The confirmatory (roche e801 eclia method) test result was "confirmed non-reactive".This medwatch will apply to the elecsys hbsag ii assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the elecsys hiv duo assay.

• Brand Name: ELECSYS HBSAG II
• Common Device Name: TEST, HEPATITIS B
• 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: 25333761
• Report Number: 1823260-2026-02129
• Device Sequence Number: 9619246
• Product Code: LOM
• UDI-Device Identifier: 07613336183076
• UDI-Public: 07613336183076
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160019
• 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): 05/29/2026

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: 08814848162
• 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: 05/07/2026
• Initial Report FDA Received Date: 05/29/2026
• 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