MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT HIV AG/AB COM; HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES

Catalog Number 04J27-27

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 09/19/2017

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 4j27 that has a similar product distributed in the us, list number 2p36.

Event Description

The customer observed (b)(6) results while using the architect hiv ag/ab combo reagents.The following data was provided.(b)(6).No impact to patient or donor management was reported.

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, device history review, labeling review, and accuracy testing.No adverse trend was identified for the customer's issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.The product was not returned.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.Sensitivity was also evaluated by testing two commercially available seroconversion panels, zeptometrix (b)(6).The product lots detected the same bleeds as (b)(6) as historical architect (b)(6) results provided by zeptometrix.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.

• Brand Name: ARCHITECT HIV AG/AB COM
• Type of Device: HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• 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: 6938459
• MDR Text Key: 90174501
• Report Number: 3002809144-2017-00134
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2018
• Device Catalogue Number: 04J27-27
• Device Lot Number: 78017LI00
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2017
• 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