MAUDE Adverse Event Report: ABBOTT ARCHITECT SYPHILIS TP REAGENT KIT; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Catalog Number 08D06-32

Device Problem False Negative Result (1225)

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

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 8d06-32 that has a similar product distributed in the us, list number 8d06-41.

Event Description

The customer reported a false nonreactive architect (b)(6) tp results on a (b)(6)-yr old female patient.Results provided: (b)(6) 2020 = 0.59 s/co, immunochromatography, rpr, and tpla are all positive.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for the architect syphilis tp assay lot 12419be00 included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and inhouse testing of retained kits with the complaint lot number.Return testing was not completed as returns were not available.Trending review determined no trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Inhouse testing determined that the sensitivity performance is not negatively impacted.Labeling was reviewed and adequately addresses the customer issue.Based on our investigation, no systemic issue or deficiency with the architect syphilis tp reagent lot 12419be00 was identified.

• Brand Name: ARCHITECT SYPHILIS TP REAGENT KIT
• Type of Device: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Manufacturer (Section D): ABBOTT; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10707594
• MDR Text Key: 212570799
• Report Number: 3002809144-2020-01029
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• PMA/PMN Number: K153730
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2021
• Device Catalogue Number: 08D06-32
• Device Lot Number: 12419BE00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(4).; ARC I2K PROC MOD, 03M74-01, (B)(4).
• Patient Age: 70 YR