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 Date 04/01/2018

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 false (b)(6) architect (b)(6) results on one patient.The results provided were: (b)(6) 2017 =(b)(6) / (b)(6) 2018 = (b)(6) / (b)(6) 2019 = (b)(6).The patient has not been vaccinated.There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets determined normal complaint activity for lot 01347fn00 and no trends were identified for the issue for the product.Return testing was not completed as returns were not available.Historical performance of reagent lot 01347fn00 was evaluated using world wide data from abbottlink.The median population result for the lot is comparable with all other lots in the field and within established baselines and confirms no systemic issue for the lot.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.The overall sensitivity of the architect anti-hbs assay was estimated to be 95.97% at the lower 95% confidence level.Therefore, false elevated and false depressed results may occur.Based on the investigation no product deficiency was identified for the architect anti-hbs reagent, lot 01347fn00.

• 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: 9667187
• MDR Text Key: 205520584
• Report Number: 3008344661-2020-00010
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2020
• Device Catalogue Number: 07C18-29
• Device Lot Number: 01347FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I1000SR ANALYZER, LN 01L86-01,; ARCHITECT I1000SR ANALYZER, LN 01L86-01,; SERIAL # (B)(4); SERIAL # (B)(4)