MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HBS; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number	11820524160
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys anti-hbs results from two patient samples tested on the cobas e 602 module.One example of discrepant results was provided: the initial result was 9.58 iu/l (indeterminate).The first repeat result was 3.50 iu/ml with a data flag (negative).The second repeat result was 32.29 with a data flag iu/ml (positive).The initial result was not reported outside the laboratory, as patient samples with "indeterminate" initial results are rerun twice.The result was reported as "negative".
Additional Manufacturer Narrative
The cobas e 602 module serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The investigation included a review of the data set provided by the customer: the calibration results were within the specified ranges.The qc results were within the specified ranges.There was no indication of a performance issue with the reagent.The alarm trace contained sample quality-related alarms.The field service engineer (fse) inspected the module and did not find a cause for the event.He verified the module's performance with mechanical checks.A general reagent problem was not detected because the qcs before the event were within the specified ranges, and isolated non-reproducible results do not represent a general malfunction of the assay.The cause of the event could not be determined based on the provided information.The investigation did not identify a product problem.

• Brand Name: ELECSYS ANTI-HBS
• Common Device Name: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• 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: 22715427
• Report Number: 1823260-2025-02394
• Device Sequence Number: 9207021
• Product Code: LOM
• UDI-Device Identifier: 07613336159781
• UDI-Public: 07613336159781
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010054
• 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,Followup
• Report Date (Section B): 10/31/2025

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: 09/30/2025
• Device Catalogue Number: 11820524160
• Device Lot Number: 82708000
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 10/31/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALBUTEROL; NORVASC; TYLENOL; ZYLOPRIM
• Patient Age: 67 YR
• Patient Sex: Female