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

Catalog Number 02G22-30

Device Problem False Negative Result (1225)

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

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier = (b)(6).All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 02g22-30 that has a similar product distributed in the us, list number 04p53-35.

Event Description

The customer observed false nonreactive architect (b)(6) qualitative ii results for two patients.The following data was provided, no units of measure were provided (<1.00 s/co is nonreactive, >/= 1.00 s/co is reactive): patient #1 initial result was 0.82, repeat after ultra-centrifugation was 0.83.The sample was tested using roche, which was 1.45 (reactive).The sample was tested for percent neutralization for confirmation with the following results: (b)(6): 0.14; (b)(6): 0.74 (< 0.7 s/co % neutralization is not applicable ); percent neutralization was 104.65% (confirmed positive); patient #2 initial result was 0.87, repeat after ultra-centrifugation was 0.89.The sample was tested using roche, which was 1.20 (reactive).The sample was tested for percent neutralization for confirmation with the following results: (b)(6): 0.17; (b)(6): 0.80.Percent neutralization was 99.87% (confirm positive).There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false non-reactive architect hbsag qualitative ii, lot number 07210fn00, results included a search for similar complaints, review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.Review of trending reports for the architect hbsag qualitative ii reagent did not identify any related trends.Using worldwide field data, the performance of reagent lot 07210fn00, and associated sublots manufactured with the same material, were evaluated and are performing similar to other reagent lots in the field confirming there was no systemic issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and found to adequately address the issue under review.No systemic issue or deficiency of the architect hbsag qualitative ii reagent was identified.Based on the information provided and abbott diagnostics' complaint investigation, no product deficiency was identified.

• 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: 10159790
• MDR Text Key: 230664667
• Report Number: 3008344661-2020-00049
• 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: 07/08/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2020
• Device Catalogue Number: 02G22-30
• Device Lot Number: 07210FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 07/01/2020
• Supplement Dates FDA Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000 PROCESSING MODULE,; ARCHITECT I2000 PROCESSING MODULE,; LIST# 03M74-01, SERIAL# (B)(6); LIST# 03M74-01, SERIAL# (B)(6)