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

Catalog Number	08814848190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable elecsys hbsag ii assay result for a patient sample tested on a cobas e 801 analytical unit.The initial result was 1.03 coi (reactive), accompanied by a data flag.The sample was repeated twice, with results of 0.386 coi and 0.327 coi (both non-reactive), accompanied by a data flag.
Additional Manufacturer Narrative
Qc and calibration were acceptable.The investigation determined that the initially reactive result was due to a preceding high ecl signal on the same measuring cell, which was flagged with the respective carovr alarm.With regards to the first run results being slightly higher than the second run results (having the same clinical interpretation), it is likely due to pre-analytical issues.The elecsys hbsag ii assay performs within specification.

• 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: 24621486
• Report Number: 1823260-2026-00954
• Device Sequence Number: 21366737
• Product Code: LOM
• UDI-Device Identifier: 07613336168103
• UDI-Public: 07613336168103
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 05/08/2026

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: 08814848190
• Device Lot Number: 90551701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 05/08/2026
• 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