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	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas e 801 analyzer (serial number: (b)(6)).The investigation determined that the elecsys hbsag ii assay performed within specifications.No reagent-specific issue was identified, and the reagent met all defined specifications.A review of calibration and quality control data confirmed that all results were within expected ranges.Internal testing of seven samples at the cir laboratory yielded non-reactive results in both the first and second measurements, and no confirmatory testing was deemed necessary.The positive result reported by the customer for sample 2 could not be reproduced during the investigation.Additionally, the presence of negative coi values was determined to be within the defined specifications for the cobas e 801 module.The analyzer and assay remained in operation at the customer site, and no further issues were reported.
Event or Problem Description
The initial reporter alleged discrepant results with the elecsys hbsag ii assay on the cobas e 801 module for two patient samples.For sample 1, testing on (b)(6) 2020 yielded a result of -0.0942 (negative).Subsequent testing on (b)(6) 2020 produced results of -0.0987 (negative), -0.0809 (negative), -0.0598 (negative), -0.0546 (negative), 0.0998 (negative), and -0.114 (negative) across various tubes and matrices, including plasma and serum.For sample 2, testing on (b)(6) 2020 yielded a result of -0.00032 (negative) in serum.On (b)(6) 2020, testing of the same sample in plasma produced a result of 0.275 (positive).The results were not confirmed with an hbsag confirmatory test.No additional confirmatory testing was performed, and the positive result for sample 2 could not be reproduced.The results were not reported to the patients.

• 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: 23084508
• Report Number: 1823260-2025-03102
• Device Sequence Number: 11923642
• Product Code: LOM
• UDI-Device Identifier: 04015630940028
• UDI-Public: 04015630940028
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 09/18/2025

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: 04/30/2020
• Device Catalogue Number: 07251076190
• Device Lot Number: 42036900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 09/18/2025
• 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