MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT HBSAG QUALITATIVE II

Model Number N/A

Device Problem False Negative Result (1225)

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

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no additional patient information provided by the customer.This report is being filed on an international product, list number 02g22 that has a similar product distributed in the us, list number 4p53.

Event Description

The customer reported false nonreactive architect (b)(6) assay results for two patients.The customer provided: pt#1 initial = 0.68 s/co, repeat 0.74 s/co, centrifuge repeat = 2.28 s/co (<1.00 s/co nonreactive; >= 1.00 s/co reactive).Neutralizing test (b)(6) = 0.78 s/co (>=.07 reactive); (b)(6) = 98.9 % neutralization (reactive).Testing with roche analyzer: initial = 2.39 s/co; repeat 5.1.S/co (reactive).Pt#2 initial = 0.65 s/co, repeat = 0.74 s/co, repeat centrifuge = 1.49 s/co.(<1.00 s/co nonreactive; >= 1.00 s/co reactive).Neutralizing test (b)(6) = 0.84 s/co (>=0.7 or greater) (b)(6) = 101.4 % neutralization (positive).Roche analyzer: initial = 1.49 s/co (reactive), repeat centrifuge =1.71s/co.Customer considers the two initials with immediate repeat (before centrifuge) to be false nonreactive as results these two patients had from the previous year were low reactive.There was no impact to patient management reported.

Manufacturer Narrative

The evaluation of the customers issue included a search of lot 07210fn00, which identified normal complaint activity for this lot.It included a complaint trending review, which determined no trend for product list number 2g22, for the customers issue.Customer field data was used to assess the performance of the architect hbsag qualitative ii assay.The median patient population result for lot 07210fn00 for samples within the range 0.8 to 5.25 s/co is comparable with all other lots in the field and confirms no systemic issue for the lot.Labeling was reviewed which was found to adequately addresses the current issue.Based on all available information no product deficiency was identified.This report is being filed on an international product, list number 02g22 that has a similar product distributed in the us, list number 4p53.

• Brand Name: ARCHITECT HBSAG QUALITATIVE II
• Type of Device: HBSAG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 10221530
• MDR Text Key: 231304651
• Report Number: 3008344661-2020-00055
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2020
• Device Model Number: N/A
• Device Catalogue Number: 02G22-30
• Device Lot Number: 07210FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-01, SN (B)(6) ; LN 03M74-01, SN (B)(6)