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

Catalog Number 02G22-25

Device Problems False Negative Result (1225); False Positive Result (1227)

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

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product list 2g22, that has a similar us product distributed in the us, list 4p53.An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account stated a false (b)(6) architect hbsag qualitative ii on a one month old patient.The account generated architect hbsag qualitative ii (b)(6) (0.17, 0.17 s/co) but liaison (b)(6) and liaison (b)(6).No additional testing was provided.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

Section h6 device code updated from 1227 to the corrected code of 1225.Upon retrospective review it was discovered that the device code of 1227 is incorrect and the correct code is 1225.No further followup.

Manufacturer Narrative

Through the product evaluation, 2 different sample draws using ids 21512, 818206011 generated the nonreactive hbsag results of 0.17, 0.17 s/co.On the (b)(6) 2020, a new sample draw, id 818206048, generated nonreactive hbsag of 0.15 s/co on the same instrument using the same reagent lot.Controls were running as expected.The patient was not vaccinated.The complaint evaluation for false non-reactive hbsag results included a search for similar complaints, and review of attachments, trending data, labeling, and device history records.Customer return testing was not completed as returns were not available.Historical performance of reagent lot 9304fn00 was evaluated using world wide data.Trending review determined no adverse trend for the issue for the product.Device history record review on lot 09304fn00 did not show any potential non-conformances, or deviations.Labelling was reviewed and found to adequately address the issue under review.Historical performance in the field of reagent lots using worldwide data was evaluated.The patient median result for the lot is comparable with all other lots in the field and within established baselines, confirming no systemic issue for the product lot.Based on the evaluation, no product deficiency of the architect hbsag qualitative ii assay, lot number 09304fn00 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: 10156431
• MDR Text Key: 195248758
• Report Number: 3008344661-2020-00048
• 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,Followup
• Report Date: 08/06/2020

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: 09/23/2020
• Device Catalogue Number: 02G22-25
• Device Lot Number: 09304FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 07/09/2020; 08/06/2020
• Supplement Dates FDA Received: 08/05/2020; 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR; ARCHITECT I2000SR; ARCHITECT I2000SR; LIST 03M74-02, SERIAL (B)(6) ; LIST 03M74-02, SERIAL (B)(6) ; LIST 03M74-02, SERIAL (B)(6) ; ARCHITECT I2000SR; LIST 03M74-02, SERIAL (B)(4).