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

Catalog Number 08P11-22

Device Problem False Positive Result (1227)

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

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, alinity i hbsag qualitative ii confirmatory, list 08p11-22, that has a similar product distributed in the us, list number 08p11-21.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.No further information was provided.Refer to related manufacturer report number 3008344661-2020-00007 for the device evaluation of a second lot of alinity i hbsag qualitative ii confirmatory; 3008344661-2020-00002 and 3008344661-2020-00005 for the device evaluation of the alinity i hbsag qualitative ii reagent lots.

Event Description

The customer reported false repeat reactive and confirmatory positive alinity i hbsag results.Sample id (b)(6) generated 2.33 and 2.45 s/co on the hbsag assay and multiple confirmed results with neutralization results ranging from 101 to 103% neutralization.The sample was tested at a reference lab and generated negative results on architect hbsag quantitative, architect hbsag confirmatory, and elisa methods.No impact to patient management was reported.

Manufacturer Narrative

The data associated with the discrepant results were reviewed.There were no issues with the calibrations performed using the reagent lots.There were no issues with negative and positive control values on the dates the sample was tested.However, it was noted that the control lot (8p10-10 lot 96285fn00) was expired (15 sep 19).Additionally, the architect hbsag qual ii confirmatory lot 02219fn00 was tested (14 nov 19) after the expiry date (13 nov 19).Review of complaint activity associated with the complaint lots identified normal complaint activity.Review of tracking and trending reports for the alinity i hbsag qualitative ii confirmatory assay did not identify any related trends.Return testing was not completed as returns were not available.Testing of negative panels, which mimic patient samples, was performed using an in-house retained kit of lot 07057fn00, stored at the recommended storage condition.Lot 07057fn00 is a second lot used at the customer site to test the sample.All specifications were met indicating that the lot is performing acceptably.Manufacturing documentation for the likely cause lots were 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: ALINITY I 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: 9643092
• MDR Text Key: 220246423
• Report Number: 3008344661-2020-00006
• 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: 03/19/2020

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: 11/13/2019
• Device Catalogue Number: 08P11-22
• Device Lot Number: 02219FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 01/29/2020
• Supplement Dates Manufacturer Received: 03/13/2020
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE, LIST 03R65-01; ALINITY I PROCESSING MODULE, LIST 03R65-01,; LIST 08P11-22; LIST 08P11-22; SERIAL (B)(6) , ALINITY I HBSAG QUALITATIVE II,; SERIAL (B)(6) , ALINITY I HBSAG QUALITATIVE II,