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	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's e 801 is (b)(6).The patient samples are not available for investigation.Patient 1's new sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable hbsag confirmatory elecsys results from two patient samples tested on the cobas e 801 module.The reporter stated that the patients are considered to be negative for hepatitis b.Sample 1: on (b)(6) 2023: patient 1: the hbsag confirmatory result was 50.500% (positive).The result of the hepatitis b virus polymerase chain reaction: hepatitis b virus - deoxyribose nucleic acid (hbvpcr: hbv-dna) test was "not detectable".On (b)(6) 2023: the hbsag confirmatory result was 21.200% (positive).Sample 2: on (b)(6) 2023: the hbsag confirmatory result was 28.500% (positive).
Additional Manufacturer Narrative
The investigation reviewed the calibration and quality control results.The results were within specifications.The cause of the event could not be determined as the patient samples were not available for investigation.The investigation did not identify a product problem.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18977159
• Report Number: 1823260-2024-00899
• Device Sequence Number: 6279869
• Product Code: LOM
• UDI-Device Identifier: 07613336175293
• UDI-Public: 07613336175293
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• PMA/510(K) Number: P990012
• 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): 05/09/2024

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: 09127127190
• Device Lot Number: 72911601
• 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: 03/06/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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