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

Catalog Number	08741034190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for two samples from the same patient tested with the elecsys (b)(6) gen.2 immunoassay on a cobas 8000 e 801 module.The first sample also had a questionable elecsys (b)(6) gen.2 auto confirm result on a second e 801 analyzer.This medwatch will apply to the (b)(6) auto confirm assay.Patient identifier (b)(6) for information related to the (b)(6) assay.On (b)(6) 2021, a first sample collected from the patient resulted in a (b)(6) result of (b)(6).The sample was repeated and the result was also (b)(6).The sample was tested on a second e 801 analyzer, resulting in a (b)(6) value for the (b)(6) auto confirm assay.On (b)(6) 2021, a second sample collected from the patient resulted in a (b)(6) result of (b)(6).The sample was repeated and the result was also (b)(6).The serial number of the first e 801 analyzer is (b)(4).The serial number of the second e 801 analyzer was requested, but not provided.
Additional Manufacturer Narrative
The patient samples were provided for investigation.The sample from (b)(6) 2021 was reactive when tested using 2 lots of the elecsys hbsag gen.2 immunoassay (lots 534881 and 516017).The sample from (b)(6) 2021 was non-reactive using the same two lots of hbsag gen.2 reagent.A confirmation measurement could not be done due to the very small sample volume of the (b)(6) 2021 sample.
Additional Manufacturer Narrative
During investigations, the reactive elecsys hbsag gen.2 immunoassay result for the sample from (b)(6) 2021 could also be reproduced after a 1:1 sample dilution.
Additional Manufacturer Narrative
During investigations, both the first (dated (b)(6) 2021) and second sample (dated (b)(6) 2021) were tested on an abbott architect analyzer.The first sample was found to be reactive with hbsag on the abbott architect.The second sample was found to be non-reactive on the abbott architect.The hbsag results obtained on the e 801 analyzer are assumed to be correct.The reactive value of the first sample obtained with the elecsys hbsag gen.2 auto confirm assay is also assumed to be correct.No specific issue could be identified, the reagent performs within specification.

• Brand Name: ELECSYS HBSAG II AUTO CONFIRM
• Common Device Name: HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12317533
• Report Number: 1823260-2021-02363
• Device Sequence Number: 4687006
• Product Code: LOM
• UDI-Device Identifier: 07613336172902
• UDI-Public: 07613336172902
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P160019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/12/2021

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: 08741034190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 09/03/2021; 10/06/2021; 10/26/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/23/2021; 10/26/2021; 11/12/2021
• 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: Female