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

Catalog Number 08D06-77

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/18/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 8d06-39 has a similar product distributed in the us, list number 8d06-31/-41.

Event Description

The customer observed false nonreactive architect syphilis results generated for a 70 year old female patient.The following data was provided: (b)(6) 2022 initial result = 0.89 s/co, repeat = 0.95 s/co, repeat with another method (fluorescence) = 19.21 (positive), tppa = positive.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely reactive architect syphilis results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history review, and in house testing was completed.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot 32478be01 and the complaint issue.In-house specificity testing was completed with complaint lot number 32478be01.All controls met specifications and no false reactive results were obtained, indicating that the specificity performance is not negatively impacted.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the architect syphilis reagent for lot 32478be01 was identified.

• Brand Name: ARCHITECT SYPHILIS TP REAGENT KIT
• Type of Device: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14850498
• MDR Text Key: 299093891
• Report Number: 3002809144-2022-00224
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K153730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2022
• Device Catalogue Number: 08D06-77
• Device Lot Number: 32478BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Age: 70 YR
• Patient Sex: Female