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

Catalog Number 04J27-27

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is being filed on an international product, list number 04j27 that has a similar product distributed in the us, list number 02p36.(b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(4).

Event Description

The customer indicated that unnecessary treatment was administered to an infant after the mother tested (b)(6) using the architect hiv ag/ab assay.The customer provided the following information: on (b)(6) 2016: (b)(6): (b)(6) (not retested in duplicate) it was indicated that this specimen was drawn prior to labor.On (b)(6) 2016: a new specimen was drawn and generated a result of (b)(6) (not retested in duplicate).Western blot and viral load were (b)(6).No specific information has been provided as to what specific prophylactic treatment was received by the infant or the mother.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, in-house testing, a batch record review, a search for similar complaints, and a review of labeling.Return material was not available from the customer.Review of the data provided by the customer confirmed the issue represents a use error.Initial reactive results were not confirmed by double retesting after re-centrifugation as required per package insert and treatment was administered without confirmation suing supplemental testing.A specificity testing protocol was executed using lot 59157li00 and met acceptance criteria and determined the reagent is performing acceptably.A batch record review did not identify any issues.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no malfunction and no product deficiency of the architect hiv ag/ab combo reagent, list number 4j27-27, lot number 59157li00, were identified.

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended.However, no systemic issue or product deficiency was identified.

• Brand Name: ARCHITECT HIV AG/AB COMBO
• 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: 5647975
• MDR Text Key: 45003800
• Report Number: 3002809144-2016-00029
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2016
• Device Catalogue Number: 04J27-27
• Device Lot Number: 59157LI00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/11/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/27/2016; 06/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2016
• 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