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

Catalog Number	09127127190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number was not provided.The investigation was limited due to the unavailability of sample material, quality control data, and calibration data.The issue appears to be sample-related, as the results were near the assay cut-off.Additionally, the confirmatory test was performed using unrecommended reagent volumes.While the ratio of reagents used was acceptable, the reduced volumes may have introduced variability due to potential pipetting inaccuracies.A definitive root cause for the reported event could not be determined based on the available information.The case was resolved locally and escalated for documentation purposes only.
Event or Problem Description
The initial reporter alleged discrepant results with the hbsag confirmatory elecsys cobas e v2 assay.The patient had a history of slightly positive hbsag ii results and negative or slightly positive hbsag confirmatory test results in prior years.On (b)(6)2022, the patient sample was tested for hbsag ii, yielding the following results: run 1: 1.16 coi; run 2 (after centrifugation): 1.16 coi; run 3: 1.28 coi; run 4 (using a new blood collection tube): 1.18 coi; and run 5: 1.22 coi.All results were repeatedly reactive.The customer performed hbsag confirmatory testing using a new reagent lot.The confirmatory test results were as follows: positive control plus confirmatory reagent (c): 0.49 coi; positive control plus comparator reagent (d): 3.76 coi.The calculated ratio (c/d*100) was 13.0%, which confirmed the sample as positive.However, the customer used 180 l + 20 l instead of the recommended 270 l + 30 l volumes for the confirmatory test.Despite the confirmed positive result, the customer reported the sample as negative based on results from an outsourced laboratory.No new blood sample could be collected from the patient.

• Brand Name: ELECSYS HBSAG CONFIRMATORY TEST
• 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: 23067273
• Report Number: 1823260-2025-02946
• Device Sequence Number: 13181816
• Product Code: LOM
• UDI-Device Identifier: 07613336175293
• UDI-Public: 07613336175293
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P160019/S014
• 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): 09/16/2025

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 Catalogue Number: 09127127190
• Device Lot Number: 582540
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 09/16/2025
• 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
• Patient Sex: Unknown