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 07C18-74

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Was this device serviced by a third party?: no.Patient identifier = sid=(b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed (b)(6) architect anti-hbs result when compare to enzyme immunoassay on one patient.The results provided were: on (b)(6) 2021, sid (b)(6), first result from architect/ repeated on architect / sid (b)(6) third result from enzyme immunoassay elisa 1800: (b)(6)/colloidal gold method=(b)(6).(b)(6).There was no reported impact to patient management.

Manufacturer Narrative

This follow up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.

Manufacturer Narrative

Component code: g01003 section d4: updated catalog no: to 07c18-74 from 07c18-29.Updated lot number: to 17362fn01 from 17362fn00.The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and field data of architect anti-hbs reagent lot 17362fn01.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Historical performance of the architect anti-hbs reagents in the field using data gathered via abbottlink from customers worldwide.This evaluation indicated that the patient median result for lot 17362fn01 are within the established limits, therefore, no unusual reagent lot performance was identified.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.A review of the product labeling concluded that the issue is sufficiently addressed.The specificity of the assay is not 100%, therefore, the occurrence of false positive results in samples tested with the architect anti-hbs assay is possible.Based on the investigation no product deficiency was identified for the architect anti-hbs assay lot number 17362fn01.

Manufacturer Narrative

This follow-up submission sends for correction on section d9 in emdr 2021 nov-30 form version: d4 catalog no: to 07c18-74 from 07c18-29; lot number: to 17362fn01 from 17362fn00.

• 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: 11440190
• MDR Text Key: 278164178
• Report Number: 3008344661-2021-00057
• 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,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2021
• Device Catalogue Number: 07C18-74
• Device Lot Number: 17362FN01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(4); ARC I2000SR INST, 03M74-02, (B)(4); ARC I2000SR INST, 03M74-02, (B)(4); ARC I2000SR INST, 03M74-02, (B)(4)