MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HBSAG II CONFIRMATORY TEST; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number	11820648122
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred on a cobas e 801 analyzer (serial number: (b)(6).The investigation was limited due to the unavailability of the patient sample for further analysis.A definitive conclusion regarding the sample status could not be determined based on the available information.The customer was advised to open a new case if a new sample from this patient or another patient exhibiting the same phenomenon becomes available.
Event or Problem Description
The initial reporter alleged inaccuracy in results obtained with the hbsag confirmatory test elecsys on the cobas e 801 module.The sample was initially tested for hbsag with results of 1.93 coi and 1.37 coi upon repetition.The sample was subsequently tested using the hbsag confirmatory test in two separate sessions.In the first session, the sample with control reagent yielded a result of 0.888 coi, and the sample with confirmatory reagent yielded a result of 0.328 coi.Control 2 with control reagent yielded a result of 3.96 coi, and control 2 with confirmatory reagent yielded a result of 0.530 coi.In the second session, the sample with control reagent yielded a result of 0.870 coi, and the sample with confirmatory reagent yielded a result of 0.359 coi.Control 2 with control reagent yielded a result of 4.13 coi, and control 2 with confirmatory reagent yielded a result of 0.526 coi.The sample was reported as reactive.Testing of the same patient sample at a different laboratory yielded a negative hbsag result, which was confirmed by molecular testing.The customer indicated that the initial dilution of the sample with confirmatory and control reagents was performed correctly at 270 l sample to 30 l reagents.The sample was not available for further investigation.

• Brand Name: ELECSYS HBSAG II 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: 23066832
• Report Number: 1823260-2025-02940
• Device Sequence Number: 9681053
• Product Code: LOM
• UDI-Device Identifier: 04015630911110
• UDI-Public: 04015630911110
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P160019/S010
• 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): 09/16/2025

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: 11820648122
• Device Lot Number: 445019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2020
• 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