MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION 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.There is no further patient information provided by the customer.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 reported a falsely elevated architect (b)(6) result on one patient.Results provided: (b)(6) = 600 miu/ml.The physician questioned the results due to no history of (b)(6) and (b)(6) vaccine not administered.Other test results provided: (b)(6) = 8 / 7.865 / 7.225 s/co; (b)(6) = negative.No impact to patient management was reported.

Manufacturer Narrative

The evaluation of complaint data for the product and likely cause lot 06339fn00 identified normal complaint activity and there are no trends for the product related to patient results.No customer returns were available for evaluation.A review of overall customer field data was performed to assess the performance of the architect anti-hbs assay and is within the established baselines confirming no systemic issues in the field.A review of the manufacturing documentation did not identify any issues associated with the customers observation.A review of labeling concluded that the issue is sufficiently addressed.No product deficiency was identified.

• Brand Name: ARCHITECT ANTI-HBS
• Type of Device: ANTI-HBS
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 9825358
• MDR Text Key: 227200172
• Report Number: 3008344661-2020-00024
• 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: 04/06/2020

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: 09/27/2020
• Device Catalogue Number: 07C18-29
• Device Lot Number: 06339FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER LIST 03M74-01; ARCHITECT I2000SR ANALYZER LIST 03M74-01; SERIAL (B)(4); SERIAL (B)(4)