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	Inadequate or Insufficient Training (1643)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 e601 module serial number was (b)(6).From product labeling for the screening assay: all initially reactive or borderline samples should be reassayed in duplicate using the elecsys hbsag ii immunoassay.The customer used the incorrect sample preparation option for the initial confirmatory test based on the initial hbsag ii coi (cutoff index).Per product labeling: for positive samples having a cutoff index = 30.0, predilute samples 1:20 with diluent universal 150 l diluted sample + 150 l hbsag confirmatory test 1 (confirmatory reagent) 150 l diluted sample + 150 l hbsag confirmatory test 2 (control reagent).The customer used an incorrect sample dilution of 1:10 for one of the confirmatory tests.Per product labeling for the confirmatory assay: predilute samples 1:20 with diluent universal.The customer did not perform precicontrol hbsag ii 2 quality control in parallel with any of the confirmatory tests.Per product labeling for the confirmatory assay: pc hbsagii2, the positive control, should always be run in parallel as a check on performance.The customer did not perform the 30¿60 min incubation period when testing the sample for any of the confirmatory tests.Per product labeling for the pretreatment of the samples using the confirmatory assay: incubation of the reactants: 30-60 minutes at 15-25 °c or overnight at 2-8 °c.The investigation determined the event was due to the customer not following instructions in product labeling for the assay.There was no product problem identified.
Event or Problem Description
There was an allegation of questionable elecsys hbsag confirmatory test results from the cobas 6000 e601 module.The initial screening result was 110.6 coi reactive).The customer did not repeat the screening assay.The customer then tested the sample using elecsys hbsag confirmatory test using the incorrect sample preparation option and determined the result was positive (74.03 coi).On (b)(6) 2026, the customer performed two more confirmatory tests for this sample using the other sample preparation options.Using the second incorrect sample preparation option, the conclusion was negative (234.4 coi).Using the correct sample preparation option, but an incorrect dilution of 1:10 instead of 1:20, the conclusion was negative (2374 coi).The customer then performed the confirmatory test for this sample using the correct sample preparation option and correct dilution.The conclusion was positive (4.39 coi).

• 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: 24858187
• Report Number: 1823260-2026-01401
• Device Sequence Number: 18778940
• Product Code: LOM
• UDI-Device Identifier: 07613336175293
• UDI-Public: 07613336175293
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 04/13/2026

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 09127127190
• Device Lot Number: 85242401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/13/2026
• 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: Female