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

Catalog Number	07251076190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter alleged discrepant results with the hbsag g2 elecsys e2g 300 assay on the cobas e 801 module.The customer reported that one patient sample initially tested positive but was later determined to be negative based on confirmatory testing.
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 its specified specificity of 99.88%.False-positive results are an expected occurrence at a frequency consistent with the assay's specificity.No additional data or statistical analysis was provided by the customer to evaluate whether the observed.Frequency of false-positive results exceeded the expected rate.The case was closed as no further information was available to support additional investigation.

• 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: 23065074
• Report Number: 1823260-2025-02923
• Device Sequence Number: 15963665
• Product Code: LOM
• UDI-Device Identifier: 04015630940028
• UDI-Public: 04015630940028
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P160019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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: 07251076190
• Device Lot Number: 454095
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2020
• 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