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

Catalog Number	11820648122
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).The sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter questioned negative results for 4 patient samples tested for elecsys hbsag confirmatory tests (hbsag confirmatory) on a cobas e 801 analytical unit where the initial hbsag results were high (positive).Of the data provided, discrepant results were identified for 1 patient sample between 2 different hbsag confirmatory reagents.This medwatch will cover hbsag confirmatory reagent with material number 11820648122.Refer to medwatch with a1 patient identifier (b)(6) for information on the hbsag confirmatory reagent with material number 09127127190.Refer to the attached data for the patient results.
Additional Manufacturer Narrative
No sample material was 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: 19311832
• Report Number: 1823260-2024-01438
• Device Sequence Number: 3076743
• Product Code: LOM
• UDI-Device Identifier: 04015630911110
• UDI-Public: 04015630911110
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• 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): 06/06/2024

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 11820648122
• Device Lot Number: 664791
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/06/2024
• 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