MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT ANTI-HBS

Catalog Number 07C18-29

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

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 anti-hbs results on one patient.The results provided were: for about one year the anti-hbs = 20-40miu/ml and the hbsag has been 200-250iu/ml; dna test one year ago -detected, currently not detected.The results of anti-hbc, anti-hbe, and hbeag are unknown.There was no reported impact to patient management.

Manufacturer Narrative

Correction to follow-up mdr section d.Medical device, 3.Manufacturing name, city, and state from incorrect: (b)(4).

Manufacturer Narrative

Complaint trending report review determined that there is are no trends for the product for the complaint issue.A search for complaints was not performed as the reagent lot was unknown.Return testing was not completed as returns were not available.Historical performance in the field of the architect anti-hbs assay using world wide data through abbottlink was evaluated.No elevation in median patient result for nonreactive specimens above established baselines was observed for any on-market lots.A review of the manufacturing documentation did not identify any issues associated with the customers observation.A review of the product labeling concluded that the issue is sufficiently addressed.Variations in results could be observed as the antibody produced by the immune system is not a homogenous species.The immune response to hbv infection and vaccination results in a variety of antibodies to different hbsag epitopes with different affinities (e.G anti- a, anti -y, anti -d, anti - pres1 and anti pres2 )and avidities within and between individuals.Based on the investigation no product deficiency was identified for the architect anti-hbs assay, list number 07c18-29.

• Brand Name: ARCHITECT ANTI-HBS
• Type of Device: ANTI-HBS
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo TX NA ; EI NA
• MDR Report Key: 8728492
• MDR Text Key: 148998626
• Report Number: 3008344661-2019-00078
• 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,Followup
• Report Date: 09/04/2019

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 Catalogue Number: 07C18-29
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 07/30/2019; 09/04/2019
• Supplement Dates FDA Received: 08/05/2019; 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LIST # 03M74-02,; ARCHITECT I2000SR, LIST # 03M74-02; ARCHITECT I2000SR, LIST # 03M74-02; SERIAL # (B)(4); SERIAL # (B)(4); SERIAL # (B)(4); ARCHITECT I2000SR ANALYZER, LIST # (B)(4); SERIAL # (B)(4)
• Patient Age: 50 YR