MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE

Catalog Number	4P53-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a (b)(6) architect hbsag result on one patient.Results provided: (b)(6) 2019 sid (b)(6) = (b)(6), confirmed (b)(6) by hbsag neutralizing confirmatory assay (b)(6).The physician questioned the result, sample was sent out for additional testing that produced a (b)(6) result.No impact to patient management was reported.
Additional Manufacturer Narrative
The evaluation of complaint data for the product and likely cause architect hbsag qualitative lot 04365fn00 identified normal complaint activity and there are no trends for the product related to patient results.No customer returns were available for evaluation.To evaluate the historical performance of the reagent lot, worldwide field data was reviewed.The median population result for the lot was comparable with all other lots in the field.Therefore, no unusual reagent lot performance was identified.A review of the manufacturing documentation did not identify any issues associated with the customers observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect hbsag qualitative (lot# 04365fn00).

• 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: 9361562
• Report Number: 3008344661-2019-00138
• Device Sequence Number: 2305703
• 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): 01/15/2020

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: 01/07/2020
• Device Catalogue Number: 4P53-25
• Device Lot Number: 04365FN00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 01/15/2020
• 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 LIST 01L86-40; ARCHITECT I1000SR ANALYZER LIST 01L86-40; LIST 04P54-25 LOT 03278FN; LIST 04P54-25 LOT 03278FN00; SERIAL (B)(6) HBSAG QUALITATIVE CONFIRMATORY; SERIAL (B)(6) HBSAG QUALITATIVE CONFIRMATORY