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

There is no further patient information provided by the customer.An evaluation is in process.A final report will be submitted when the evaluation is complete.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 (b)(6) architect anti-hbs results on one patient.The results provided were: current = (b)(6) / 1 year ago (b)(6) / 2 years ago = (b)(6) / 3 years ago = (b)(6).The patient has not been vaccinated.There was no reported impact to patient management.

Manufacturer Narrative

A review of tickets or testing could not be completed as the lot is unknown.A complaint trending report review determined that there are no trends for the product for the complaint issue.Return testing was not completed as returns were not available.Historical performance in the field of architect anti-hbs reagent lots using world wide data through abbottlink was evaluated.All lots on market have median values that do not exceed 2sd above the established baselines, confirming no systemic issues in the field.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of labeling concluded that the issue is sufficiently addressed in the labeling.Based on the investigation no product deficiency was identified for the architect anti-hbs assay.

• 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: 8907328
• MDR Text Key: 159252005
• Report Number: 3008344661-2019-00104
• 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: 09/12/2019

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: 07/30/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 09/04/2019
• Supplement Dates FDA Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER, LN 03M74-01; ARCHITECT I2000SR ANALYZER, LN 03M74-01; SERIAL # (B)(4); SERIAL # (B)(4)
• Patient Age: 45 YR