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 07C18-75

Device Problem False Positive Result (1227)

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

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.No patient information is available.This report is being filed on an international product, list number 7c18 that has a similar product distributed in the us, list number 1l82.

Event Description

The customer generated falsely positive architect (b)(6) results for one patient in comparison with another method.The following information was provided: initial result: 19.36miu/ml, repeat 18.92miu/ml.Repeated with 1:2 dilution 33.92miu/ml, repeated with 1:4 dilution 36.48miu/ml, repeated with 1:10 dilution: 34.8miu/ml.Other method (autobio platform) 0.5miu/ml (negative).No impact to patient management was reported.

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.

Manufacturer Narrative

H6 health effect impact code: f26 d8 was this device serviced by a third party? no d4: product catalog number corrected to 07c18-75 and lot number updated to 17166fn01 a review of tickets was performed for reagent lot number 17166fn01.The ticket search determined that there is normal complaint activity for the reagent lot.A review of tracking and trending did not identify any trends for the complaint issue with this reagent lot.Return testing was not completed as returns were not available.Performance testing was performed using an in house retained kit of master lot 17166fn00 which uses the same bulk reagent as customer lot 17166fn01.Acceptance criteria were met indicating the lot is performing as expected.A review of the manufacturing documentation did not identify any issues associated with the complaint issue for the reagent lot.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect anti-hbs reagent lot 17166fn01.

Manufacturer Narrative

Component code: g03001.

Manufacturer Narrative

Correction: component code is g01003, and not g03001 as previously submitted.

Manufacturer Narrative

D4 catalog no and lot number corrected from 07c18-41 / 17166fn00 to 07c18-75 / 17166fn01.

• 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: 11167622
• MDR Text Key: 226824526
• Report Number: 3008344661-2021-00010
• 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,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2021
• Device Catalogue Number: 07C18-75
• Device Lot Number: 17166FN01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR62698; ARC I2000SR INST, 03M74-02, ISR62698; ARC I2000SR INST, 03M74-02, ISR62698; ARC I2000SR INST, 03M74-02, ISR62698; ARC I2000SR INST, 03M74-02, ISR62698; ARC I2000SR INST, 03M74-02, ISR62698; ARC I2000SR INST, 03M74-02, (B)(4)