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

Catalog Number 04P54-25

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2019

Event Type  malfunction  

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 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.

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
• Type of Device: HBSAG CONFIRMATORY
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 9244816
• MDR Text Key: 219773719
• Report Number: 3008344661-2019-00127
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00380740007799
• UDI-Public: 00380740007799
• Combination Product (y/n): N
• PMA/PMN Number: P110029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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