MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY; HBSAG CONFIRMATORY

Catalog Number	04P54-25
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), (b)(6) by hbsag neutralizing confirmatory assay (hbsagc2 =(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 confirmatory lot 03278fn00 identified normal complaint activity and there are no trends for the product related to patient results.No customer returns were available for evaluation.Testing for the architect hbsag qualitative confirmatory (4p54) assay could not be completed as the reagent lot had expired.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 confirmatory (lot# 03278fn00).

• Brand Name: ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
• Common Device Name: HBSAG CONFIRMATORY
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 9361561
• Report Number: 3008344661-2019-00139
• Device Sequence Number: 2606248
• Product Code: LOM
• UDI-Device Identifier: 00380740007799
• UDI-Public: 00380740007799
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110029
• 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: 12/05/2019
• Device Catalogue Number: 04P54-25
• Device Lot Number: 03278FN00
• 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 04P53-25 LOT 04365FN00; LIST 04P53-25 LOT 04365FN00; SERIAL (B)(4) ARC HBSAG 2 RGT; SERIAL (B)(4) ARC HBSAG 2 RGT