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

Catalog Number	08814848190
Medical Device Problem Codes	False Positive Result (1227); Contamination /Decontamination Problem (2895); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys hbsag ii assay on a cobas e 801 msb/msbl analyzer.The initial result was 4.11 coi (tested on 1st e 801 (system b) after centrifugation and interpreted as reactive).The 1st repeat result was 1.43 coi (tested on a 2nd e 801 (system a) after centrifugation and interpreted as reactive).The 2nd repeat result was 0.7 coi (tested on a 3rd e 801 (emergency system) after high-speed centrifugation and interpreted as non-reactive).On (b)(6) 2026: the high-speed centrifuged sample was repeated: the 3rd repeat result was 0.545 coi (tested on system b).The 4th repeat result was 0.563 coi (tested on system a).The 5th repeat result was 0.556 coi (tested on the emergency system).The complete blood count (cbc) sample collected on (b)(6) 2026 was tested: the results were: 1.31 coi (tested on system b).1.25 coi (tested on system a).1.36 coi (tested on the emergency system).After high-speed centrifugation, the results were: 1.04 coi (tested on system b).0.982 coi (tested on system a).1.04 coi (tested on the emergency system).No questionable results were reported outside the laboratory, as the results did not match the patient's clinical diagnosis.
Additional Manufacturer Narrative
The cobas e 801 msb/msbl analyzer serial number was (b)(6).Two samples were received for investigation on (b)(6) 2026.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: 24964541
• Report Number: 1823260-2026-01554
• Device Sequence Number: 4991849
• Product Code: LOM
• UDI-Device Identifier: 07613336168103
• UDI-Public: 07613336168103
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/22/2026

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: 86355301
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 07/22/2026
• 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 Age: 36 YR
• Patient Sex: Female