MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE

Catalog Number	04P53-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported (b)(6) architect hbsag results on one patient.The results provided were: sid (b)(6) on (b)(6) 2019 initial = (b)(6) / on (b)(6) 2019 repeated = (b)(6).The sample was sent to labcorp where they generated (b)(6) results.There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of complaint tickets or testing could not be completed as the lot is unknown.The complaint trending report review determined that there are no trends for the issue for the product.Return testing was not completed as returns were not available.Historical performance of the architect hbsag assay was evaluated using world wide data from abbottlink.For patient samples around the cutoff, all lots on market have median values that do not exceed 2sd above the overall median, confirming no atypical performance for any particular lot in the field.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Labeling was reviewed and found to adequately address the issue under review.A nonreactive test result does not exclude the possibility of exposure to or infection with hepatitis b virus.A nonreactive test result in individuals with prior exposure to hepatitis b may be due to antigen levels below the detection limit of this assay or lack of antigen reactivity to the antibodies in this assay.The presence of hbsag mutations may result in a less favorable outcome in some patients and false negative results in some hbsag assays.Results obtained with the architect hbsag qualitative assay may not be used interchangeably with values obtained with different manufacturers assay methods.Based on the investigation no product deficiency was identified for the architect hbsag qualitative assay, list number 04p53-25.

• Brand Name: ARCHITECT HBSAG QUALITATIVE
• Common Device Name: HBSAG
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 8953827
• Report Number: 3008344661-2019-00109
• Device Sequence Number: 16676567
• Product Code: KSJ
• UDI-Device Identifier: 00380740007775
• UDI-Public: 00380740007775
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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: 04P53-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 09/02/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I1000SR ANALYZER, LN 01L86-40; ARCHITECT I1000SR ANALYZER, LN 01L86-40; SERIAL # (B)(4); SERIAL # (B)(4)