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 (b)(4) , that has a similar product distributed in the us, list number (b)(4).On (b)(6) 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 restandardized architect (b)(6) assay ((b)(4)) was loaded onto the architect i2000sr analyzer in order to perform a comparative study with the former assay ((b)(4)) before placing it into routine use.The customer then planned to continue using assay number (b)(4) until the study was complete.At some point, the customer noticed that the interpretation rules for assay number (b)(4) 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 (b)(4) 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 (b)(4).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.

Manufacturer Narrative

Information from the customer site provided by abbott customer service and support (css) confirmed that this customer uses editable parameters to set grayzone and high reactive interpretation flags.The customer defines the cut-off of ">100 miu/ml" (high reactive) for patient samples to guarantee immunity but has historically used only the interpretation flags, which are processed by middleware for the patient file and does not review the actual numeric values that are designated for the flags.Review of the history log shows that changes occurred for the former architect anti-hbs assay ((b)(6)) when the new restandardized architect anti-hbs assay (file 183) was installed, but no details are available on the specifics of the change, other than the install/delete assays procedure was accessed twice.It was concluded that the most likely cause of this issue was that assay (b)(6) was inadvertently deleted when the new assay (b)(6) was uploaded and then the customer had to re-install assay (b)(6) to implement the comparative study they were performing between the two assays.This re-installation as defined in labeling (assay cd-rom package insert) would have caused interpretation parameters to revert to default settings and this would cause the issue the customer experienced.However, the customer does not remember doing this and possibly was not aware of this scenario.The customer did notify their occupational health department but the notification was not acted upon, which may have avoided the revaccination of the six individuals.A review of complaint tracking and trending metrics was performed and identified no adverse trends in conjunction with the complaint issue currently under evaluation.No similar incidents relevant to this issue experienced by this customer were found.The architect i-system e-assay cd-rom-ww package insert provides information to address the current customer issue in regards to installation/deinstallation requirements.The architect system operations manual provides information on configuring editable parameters.The architect anti-hbs assay package insert provides information on the interpretation of results.Based on the available information from the customer site and from the results of this evaluation, there is no evidence to reasonably suggest a product malfunction occurred.Concomitant medical products : architect i-system e-assay cd-rom-ww ln: 0k292-58.

• 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: 5583098
• MDR Text Key: 42962720
• Report Number: 3008344661-2016-00028
• 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,Followup
• Report Date: 04/20/2016

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: 04/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other