MAUDE Adverse Event Report: ABBOTT GMBH 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 Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided by the customer.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 reported (b)(6) architect hiv results on one female patient.The results provided were first blood draw = (b)(6) / respun and retested = (b)(6) / tested on a second architect = (b)(6) / second blood draw = (b)(6) / tested by elexys cobas = (b)(6).The female had just given birth and due to her architect hiv results the baby was treated with antiretroviral drugs.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for lot 09424be00.There were no trends identified for the complaint issue.Return testing was not completed as returns were not available.Historical performance of the architect hiv ag/ab combo reagents in the field using data gathered via abbottlink from customers worldwide was evaluated.The number of standard deviations to the cut-off for the negative populations and the median values were reviewed.The values for the complaint lot is within the established limits and thus comparable to the values of other architect hiv ag/ab combo reagent lot numbers.Specificity testing was performed with a retained kit of lot 09424be00 and results of this setup did not implicate that the specificity performance of the lot is negatively impacted.The reagent kit showed normal performance without false reactive results.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.According to the package insert of the assay a repeat reactive result is only presumptive evidence of hiv p24 ag and/or hiv-1/hiv-2 ab, which requires confirmation of a supplemental assay.Based on the investigation no product deficiency was identified for the architect hiv ag/ab combo reagent, lot 09424be00.

• Brand Name: ARCHITECT HIV AG/AB COMBO
• Type of Device: HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9565546
• MDR Text Key: 219589433
• Report Number: 3002809144-2020-00026
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2020
• Device Catalogue Number: 04J27-27
• Device Lot Number: 09424BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER,; ARCHITECT I2000SR ANALYZER, LN 03M74-95,; LN 03M74-95, SERIAL # (B)(4); SERIAL # (B)(4)
• Patient Outcome(s): Other