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

Catalog Number	07251076190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged a false positive result for the hbsag g2 elecsys e2g 300 assay on the cobas e 801 analytical unit.The initial test result was 1.61 coi (reactive), while two repeat tests in the same run yielded results of 0.327 coi and 0.315 coi (both non-reactive).These tests were performed using the e-flow process.The same sample was subsequently processed manually in a hitachi cup, yielding a result of 0.321 coi (non-reactive).The sample was collected the day prior to testing, and the customer excluded incomplete coagulation as a potential cause.The results were interpreted as non-reactive based on the repeat testing outcomes.
Additional Manufacturer Narrative
The analysis was performed on a cobas e 801 analyzer (serial number: (b)(6).The investigation determined that the elecsys hbsag ii assay performed within specifications.Initial reactive results are described in the assay's instructions for use (ifu), and the customer followed the retesting procedure as outlined in the ifu, which yielded non-reactive results.A potential contributing factor to the initial reactive result was identified as pre-analytical handling.Factors such as coagulation time, centrifugation speed, and adherence to the tube manufacturer's instructions may influence results.The customer was advised to review their pre-analytical procedures.No product issue was identified, and the investigation concluded that the assay functioned as intended.

• Brand Name: ELECSYS HBSAG II
• Common Device Name: HEPATITIS B 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
• MDR Report Key: 23073485
• Report Number: 1823260-2025-02986
• Device Sequence Number: 15951772
• Product Code: LOM
• UDI-Device Identifier: 04015630940028
• UDI-Public: 04015630940028
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P160019
• 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): 09/17/2025

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: 10/31/2020
• Device Catalogue Number: 07251076190
• Device Lot Number: 45409502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/17/2025
• 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