MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT ANTI-HBS REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 07C18-42

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, architect (b)(6), list 7c18, that has a similar product distributed in the us, (b)(4), list number 1l82.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.No further information was provided.(b)(6).

Event Description

The customer obtained (b)(6) architect (b)(6) results.Sample id (b)(6) generated (b)(6) and repeat sid (b)(6).The sample generated a (b)(6) result using an elisa method.The sample also generated (b)(6) result of (b)(6) result of (b)(6).No adverse impact to patient management was reported.

Event Description

The customer obtained falsely elevated architect anti-hbs results.Sample id (b)(6) generated 434.3 and repeat (sid (b)(6)) 402.77 miu/ml.The sample generated a negative result using an elisa method.The sample also generated hbsag result of 12.2 iu/ml, hbeab 0.01 s/co and anti-hbc ii result of 10.63 s/co.No adverse impact to patient management was reported.

Manufacturer Narrative

H6 health effect impact code: f26 h6 component code: g01003 d8 was this device serviced by a third party? unknown.The complaint investigation included a search for similar complaints, in-house kit testing and the review of the complaint text, trending data, labelling, and device history records.Return testing was not completed as returns were not available.In house testing using a retained kit of lot 19678fn00 met acceptance criteria indicating the lot is performing as expected.Trending review determined no adverse trend for the issue for the product.Device history record review of lot 19678fn00 did not show any non-conformances or deviations.Labelling was reviewed which adequately addresses the issue under review.The literature article "interferences in immunoassay", by tate and ward (2004), clin biochem rev, vol 25, 105 was reviewed.This article indicates analytical interference can lead to falsely elevated results and according to the literature, there is no single procedure that can rule out all interferences.It is important to recognize the potential for interference in immunoassay and to put procedures in place to identify them wherever possible.Most important is a consideration of the final clinical picture.If there is any clinical suspicion of discordance between the clinical and the laboratory data an attempt should be made to reconcile the difference.The detection of interference may require the use of an alternate assay, or measurement before and after treatment with additional blocking reagent or following dilution of the sample in non-immune serum.Based on the investigation, no systemic issue or deficiency of the architect anti-hbs assay, lot number 19678fn00 was identified.

Manufacturer Narrative

This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• Brand Name: ARCHITECT ANTI-HBS REAGENT KIT
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• MDR Report Key: 11130726
• MDR Text Key: 238338242
• Report Number: 3008344661-2021-00004
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• PMA/PMN Number: P050051
• 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: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Catalogue Number: 07C18-42
• Device Lot Number: 19678FN00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)