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

Catalog Number	07251076190
Medical Device Problem Codes	False Positive Result (1227); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complete e1 initial reporter establishment name is: (b)(6) hospital.The cobas e 801 analytical unit serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable reactive elecsys hbsag ii result from the cobas e 801 analytical unit for one patient.The initial result was 1.06 coi, and the repeat result was 0.48 coi.The customer believes the result of 0.48 coi is correct.The initial result triggered an alarm on the analyzer.
Additional Manufacturer Narrative
The customer stated that the initial result triggered a "carry over" alarm.Based on the information provided, the investigation determined that the event was consistent with the customer's failure to follow the assay's instructions for use.Per product labeling, "all initially reactive or borderline samples should be retested in duplicate using the elecsys hbsag ii." the investigation did not identify a general reagent issue.

• 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: 23096948
• Report Number: 1823260-2025-03196
• Device Sequence Number: 8731111
• Product Code: LOM
• UDI-Device Identifier: 04015630940028
• UDI-Public: 04015630940028
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 01/19/2026

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: ASKU
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 01/19/2026
• 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