MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT ANTI-HBS

Catalog Number 07C18-33

Device Problem False Positive Result (1227)

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

Event Date 10/26/2019

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, anti-hbs list 7c18 has a similar product ausab, distributed in the us, list number 1l82.An evaluation is in process.A final report will be submitted when the evaluation is complete.Section a patient information: all available patient information was included.Additional patient details are not available.

Event Description

The customer reported false elevated architect anti-hbs results for one sample.The customer indicated the anti-hbs results were inconsistent with the other hepatitis b results.Sample id (b)(4) generated anti-hbs results of 24.8 and 23.81 miu/ml.The sample generated positive results for hbsag (266.6, 188.43 iu/ml), hbeag (14.6, 14.45 s/co) and anti-hbc (10.87, 11.21 s/co) and non-reactive anti-hbe (0.38, 0.39 s/co).No impact to patient management was reported.

Manufacturer Narrative

Investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of the manufacturing documentation, review of field data, and a review of labeling.Return testing was not completed as returns were not available.Review of complaint trending reports did not identify any trends for the architect anti-hbs assay.No other complaints were identified for reagent lot 02351fn00.Worldwide field data was used to evaluate the performance of reagent lot 02351fn00.This evaluation indicated that the patient median result for the lot was comparable with all other lots in the field and confirms no systemic issue.Manufacturing documentation for the reagent lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information, no systemic issue or deficiency of the architect anti-hbs assay was identified.

• Brand Name: ARCHITECT ANTI-HBS
• Type of Device: ANTI-HBS
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 9314655
• MDR Text Key: 191107211
• Report Number: 3008344661-2019-00132
• 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
• Report Date: 01/06/2020

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 Expiration Date: 06/15/2020
• Device Catalogue Number: 07C18-33
• Device Lot Number: 02351FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR; ARCHITECT I2000SR, LIST 03M74-02; LIST 03M74-02, SERIAL (B)(6) ; SERIAL (B)(6)