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	09/28/2019
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 false repeat reactive architect hbsag result on one patient.Results provided: (b)(6) 2019 sid (b)(6) = 1.38 / 1.29 / 1.43 s/co.Architect hbsag qualitative confirmatory testing = 102.364 (confirmed reactive).Patient was nonreactive on (b)(6) 2019 and (b)(6) 2019 (no data provided).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 04330fn00 identified normal complaint activity and there are no trends for the product related to patient results.No customer returns were available for evaluation.Additionally, clinical testing of the architect hbsag qualitative confirmatory assay has been evaluated with a retained in-house kit of the same lot# 04330fn00 and met all specifications, confirming that this lot is meeting the product requirements.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# 04330fn00).

• 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: 9244816
• Report Number: 3008344661-2019-00127
• Device Sequence Number: 2054316
• Product Code: LOM
• UDI-Device Identifier: 00380740007799
• UDI-Public: 00380740007799
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/13/2019

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 Expiration Date: 01/07/2020
• Device Catalogue Number: 04P54-25
• Device Lot Number: 04330FN00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 12/13/2019
• 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 LIST 01L86-01; ARCHITECT I1000SR ANALYZER LIST 01L86-01; LIST 04P53-25 LOT 04365FN00; LIST 04P53-25 LOT 04365FN00; SERIAL (B)(4), ARCHITECT HBSAG QUAL; SERIAL (B)(4), ARCHITECT HBSAG QUAL