MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HBE; ANTI-HBE TEST

Catalog Number	07026838190
Medical Device Problem Codes	False Positive Result (1227); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys anti-hbe and elecsys anti-hbc ii results for 1 patient sample on a cobas e 801 analytical unit.This medwatch will cover anti-hbe.Refer to medwatch with a1 patient identifier (b)(6) for information on the anti-hbc ii results.On (b)(6) 2025, the initial anti-hbe result was 0.732 coi, interpreted as positive, and the initial anti-hbc result was 0.212 coi, interpreted as reactive.The customer questioned the results as they were inconsistent with the patient's clinical symptoms which prompted them to repeat the sample.The sample was repeated on another competitor analyzer and the anti-hbe result was 1.26 coi interpreted as non-reactive, and the anti-hbc result was 3.99 coi, interpreted as non-reactive.On (b)(6) 2025, a new sample was collected from the patient and the anti-hbe result was 0.820 coi, interpreted as reactive, and the initial anti-hbc result was 0.212 coi, interpreted as reactive.The sample was also repeated on the competitor analyzer and the anti-hbe result was 1.23 coi, interpreted as non-reactive, and the initial anti-hbc result was 4.13 coi, interpreted as non-reactive.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.The patient samples were requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
The alarm trace did not contain a conspicuous event.The sample was not available for investigation.Based on the calibration and qc data, a general reagent issue could be excluded.The investigation did not identify a product problem.

• Brand Name: ELECSYS ANTI-HBE
• Common Device Name: ANTI-HBE TEST
• 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 46250-0457
• MDR Report Key: 23074092
• Report Number: 1823260-2025-03008
• Device Sequence Number: 4786448
• Product Code: LOM
• UDI-Device Identifier: 04015630940134
• UDI-Public: 04015630940134
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P190005/S002
• 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): 01/28/2026

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 07026838190
• Device Lot Number: 82385901
• 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: 08/26/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 01/28/2026
• 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