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 07C18-29

Device Problem High Test Results (2457)

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

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information: female patient, dob (b)(6) ; male patient, dob (b)(6).This report is being filed on an international product, list number 07c18 that has a similar product distributed in the us, list number 01l82.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false reactive architect (b)(6) results on two patients who were undergoing injections of immunoglobulins.The following data was provided ((b)(6) cutoff <10 miu/ml): (b)(6).

Manufacturer Narrative

H6 health effect impact code: f26 h6 component code: g01003 d8: was this device serviced by a third party? no.The complaint investigation included a search for similar complaints, and the review of the complaint text, trending data, labelling, and device history records.Return testing was not completed as returns were not available.The lot search review did not identify an increase in complaint activity for the issue of falsely elevated patient results.A review of tracking and trending did not identify any trend regarding commonalities for lot number and complaint issue.Device history record review did not identify any issues associated with lot 13534fn00 and the complaint issue.Labelling and literature were reviewed which adequately addresses the issue under review.Median patient result for lot 13534fn00 falls within 1sd (standard deviation) of the established baseline, indicating this reagent lot is performing acceptably on market and is comparable with other lots in the field.The overall specificity for the architect anti-hbs assay (determined by considering result values of = 10.00 miu/ml as reactive and result values of < 10.00 miu/ml as nonreactive) was estimated to be 99.22% at the lower 95% confidence level, therefore false reactive results may at times occur.An elevation in results is possible following injections of immunoglobulin, however studies designed specifically to assess the interference of immunoglobulin injections on the detection of anti-hbs antibodies using the architect anti-hbs assay have not been performed.False elevated results may arise as a result of sample or reagent integrity issues at time of testing and details regarding sample and reagent handling are provided within the product package insert.The product package insert states that if the anti-hbs results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.For diagnostic purposes, results should be used in conjunction with patient history and other hepatitis markers for diagnosis of acute, chronic, or recovered infection.In this case, nonreactive results were obtained for hbsag.Based on the investigation, no systemic issue or deficiency of the architect anti-hbs assay, lot number 13534fn00 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: 11127186
• MDR Text Key: 255585997
• Report Number: 3008344661-2021-00003
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2021
• Device Catalogue Number: 07C18-29
• Device Lot Number: 13534FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR54467; ARC I2000SR INST, 03M74-02, ISR54467; ARC I2000SR INST, 03M74-02, ISR54467