MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT AUSAB; ANTI-HBS

Catalog Number 07C18-33

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product (b)(4), that has a similar us product distributed in the us, (b)(4).The ticket searches determined normal complaint activity for the complaint lot.The complaint trending report review determined that there is no adverse trend for the issue for the product.Customer field data was used to assess the performance of the architect anti-hbs assay using world wide data.The median population result for the lot is comparable with all other lots in the field and within established baselines.A review of the product quality history for the lot number using search of the corrective and preventive actions system did not identify issues associated with the customer observation.Labeling was reviewed which adequately addresses the current issue.No customer returns were available for evaluation.No product deficiency was identified.

Event Description

The account observed false positive architect anti-hbs (21.62, 22.55 miu/ml) on a patient who tested other methods (lumipulse) negative.The patient was hbsag qualitative negative and architect anti-hcv negative.No impact to patient management was reported.No specific patient information was provided.

• Brand Name: ARCHITECT AUSAB
• Type of Device: ANTI-HBS
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• Manufacturer Contact: christian lee ; 100 abbott park road; dept 09b9, bldg cp01-3; abbott park, IL 60064-3537 ; 224668-294
• MDR Report Key: 9950865
• MDR Text Key: 202565287
• Report Number: 3008344661-2020-00030
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2020
• Initial Date FDA Received: 04/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1