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

Catalog Number 02G23-25

Device Problem False Negative Result (1225)

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

Event Date 02/28/2020

Event Type  malfunction  

Manufacturer Narrative

Patient information: no patient specific information was provided.This report is being filed on an international product, architect hbsag qualitative ii confirmatory, list 2g23, that has a similar product distributed in the us, hbsag confirmatory, list number 4p54.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer obtained a (b)(6) architect hbsag qualitative ii confirmatory result.Sample id (b)(6) generated (b)(6) results on roche (b)(6).The sample was tested neat on the architect hbsag qualitative ii confirmatory assay and generated an not confirmed result with c1 (b)(6) and c2 (b)(6).The sample was repeated neat generating similar not confirmed results of c1 (b)(6) and (b)(6).The sample was diluted 1:500 and generated confirmed (b)(6) result with c1 (b)(6) and %neutralization of 99.97%.No impact to patient management was reported.

Manufacturer Narrative

Correction to section d2: product code was change from ksj to lom.Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, in-house testing, review of manufacturing documents and a review of labeling.Return testing was not completed as returns were not available.The customer's instrument logs were reviewed, which confirmed the information provided by the customer.Review of complaint trending reports did not identify any trends for the architect hbsag qualitative ii confirmatory assay.Normal complaint activity was identified for reagent lot 04338fn00.Clinical sensitivity testing was performed using a retained kit of the compaint lot.All specifications were met indicating that the lot is performing acceptably.Manufacturing documentation for the reagent lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect hbsag qualitative ii confirmatory assay was identified.

• Brand Name: ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY
• Type of Device: HBSAG CONFIRMATORY
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 9825961
• MDR Text Key: 225593991
• Report Number: 3008344661-2020-00026
• 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: 04/24/2020

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: 05/07/2020
• Device Catalogue Number: 02G23-25
• Device Lot Number: 04338FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 04/20/2020
• Supplement Dates FDA Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR, LIST 03M74-02,; ARCHITECT I2000SR, LIST 03M74-02,; SERIAL (B)(6) ; SERIAL (B)(6)