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	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The investigation reviewed the data set provided by the customer: the calibration and qc results were within the specified ranges.The elecsys hbsag ii non-reactive assay result was confirmed by the hepatitis b virus polymerase chain reaction (hbv pcr) assay.The elecsys hbsag ii assay is performing within specifications.
Event or Problem Description
The initial reporter received questionable elecsys hbsag ii results from one patient sample tested on the cobas e 801 analytical unit.On (b)(6) 2026: the initial result from the analyzer using the first reagent pack was 0.506 coi (non-reactive).The first repeat result from the analyzer using a second reagent pack was 0.540 coi (non-reactive).The second repeat result from the abbott alinity was 88.29 s/co (reactive).The third repeat result from the abbott alinity was 78.41 s/co (reactive).On (b)(6) 2026: the result of the hepatitis b virus polymerase chain reaction (hbv pcr) assay from the cobas c 6800 was "non-reactive.".

• 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: 25034125
• Report Number: 1823260-2026-01693
• Device Sequence Number: 15713216
• Product Code: LOM
• UDI-Device Identifier: 07613336168103
• UDI-Public: 07613336168103
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 04/29/2026

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: 08814848190
• Device Lot Number: 905517
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/29/2026
• 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