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

Catalog Number	02P36-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7731271
• Report Number: 3002809144-2018-00094
• Device Sequence Number: 16541313
• Product Code: MZF
• UDI-Device Identifier: 00380740003890
• UDI-Public: 00380740003890
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02P36-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other