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

Catalog Number 02P36-25

Device Problem False Positive Result (1227)

Patient Problem No Code Available (3191)

Event Date 07/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.

Event Description

A literature article diagnostic accuracy of 4th generation architect hiv ag/ab combo assay and utility of signal-to-cutoff ratio to predict false positive hiv tests in pregnancy published in the american journal of obstetrics and gynecology (jun 15, 2018) by drs adhikari, macias, white, rogers, mcintire, and roberts at the department of obstetrics and gynecology, university of texas southwestern medical center in dallas, texas usa reported false reactive architect hiv ag/ab combo results which impacted some pregnant patient and babies.Multiple falsely positive results were observed while using architect hiv ag/ab combo reagent for pregnant patients.Other methods were hiv negative, including quantitative hiv-1 rna polymerase chain reaction (pcr viral load), multispot hiv-1/hiv-2 rapid differentiation assay (biorad), and qualitative rna assay (hologic).The patients received interventions that included maternal intrapartum zidovudine, neonatal zidovudine only (prophylaxis initiated), and neonatal zidovudine plus nevirapine (prophylaxis initiated).Other interventions included breast-feeding delays for hiv results and neonatal hiv testing.No specific values per patient were provided and no further patient details were provided.

Manufacturer Narrative

Further investigation of the customer issue included a review of the article by a cross functional team, a search for similar complaints, review of field data, and a review of labeling.No adverse trend was identified for the issue.No return patient sample was available as this was a literature article.Historical performance of the all available lots was evaluated using world wide data.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no 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: 7731271
• MDR Text Key: 115536165
• Report Number: 3002809144-2018-00094
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 00380740003890
• UDI-Public: 00380740003890
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02P36-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other