MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT ANTI-HBS

Catalog Number 07C18-25

Device Problem Use of Incorrect Control/Treatment Settings (1126)

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

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 07c18, that has a similar product distributed in the us, list number 01l82.On 15 april 2016, no further patient information had been forthcoming.This issue was previously reported under mfr report# 3008344661-2016-00017 as part of a multiple patient identifier.(b)(4).

Event Description

The customer reports that on (b)(6) 2016, the assay file for the restandardised architect (b)(6) assay (assay number 183) was loaded onto the architect i2000sr analyzer in order to perform a comparative study with the former assay (assay number 131) before placing it into routine use.The customer then planned to continue using assay number 131 until the study was complete.At some point, the customer noticed that the interpretation rules for assay number 131 had changed.The following was provided by the customer: former rules: negative = less than 10 miu/ml; reactive/equivocal = 10 - 100 miu/ml; and, high reactive = greater than 100 miu/ml.After installation of the new assay file: negative = less than 10 miu/ml; reactive/equivocal = 10 - 1000 miu/ml; and, high reactive = greater than 1000 miu/ml.Patient results were being reported based on the interpretation rules in the new assay file for assay number 131 and as a consequence 45 patient results were released with the incorrect interpretation.Of these 45, six received unnecessary vaccinations.No individual specific patient data / information is available.There have been no serious injuries reported due to this issue.The customer states that no one in the lab edited the assay files for assay number 131.Abbott registration could not find any similar customer calls for this issue and has requested that the customer send the error log and assay parameter log for review.

• Brand Name: ARCHITECT ANTI-HBS
• Type of Device: ANTI-HBS
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• Manufacturer (Section G): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 5583097
• MDR Text Key: 43175633
• Report Number: 3008344661-2016-00029
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P050051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 07C18-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other