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	04/09/2026
Type of Reportable Event	Malfunction
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 (geenius 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".The sample was repeated because of the initially reactive results.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.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The hiv duo result was obtained on cobas e801 module with serial number (b)(6).The investigation is ongoing.

• 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: 25333764
• Report Number: 1823260-2026-02130
• Device Sequence Number: 13212970
• 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