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 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 08d06-77 that has a similar product distributed in the us, list number 08d06-31/-41.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false negative architect syphilis tp results for one patient with a clinical diagnosis of shortness of breath.The architect syphilis results were compared to other platform methods.The following data was provided: architect syphilis result = 0.65 s/co; repeat result = 0.66 s/co tppa result = positive colloidal gold result = positive johnson & johnson method = 120 s/co (strong positive) the customer performed a dilution verification to rule out hook effect of the assay.A 1:10 dilution was performed, and the result was 0.11 s/co as well as a 1:100 dilution and the result was 0.06 s/co.The qc was in range and sample appeared normal.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation 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 in-house testing.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the reagent lot performs as expected for this product.A review of tracking and trending did not identify any related trends for the product for the issue.A review of the device history record did not identify any non-conformances or deviations with lot 54393be01 and the complaint issue.In house testing of a retained reagent kit of the complaint lot was performed.All controls met specifications and no false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for architect syphilis tp reagent lot 54393be01.

Event Description

The customer reported false negative architect syphilis tp results for one patient with a clinical diagnosis of shortness of breath.The architect syphilis results were compared to other platform methods.The following data was provided: architect syphilis result = 0.65 s/co; repeat result = 0.66 s/co.Tppa result = positive.Colloidal gold result = positive.Johnson & johnson method = 120 s/co (strong positive).The customer performed a dilution verification to rule out hook effect of the assay.A 1:10 dilution was performed, and the result was 0.11 s/co as well as a 1:100 dilution and the result was 0.06 s/co.The qc was in range and sample appeared normal.There was no impact to patient management reported.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18234295
• MDR Text Key: 330117019
• Report Number: 3002809144-2023-00480
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08D06-77
• Device Lot Number: 54393BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2023
• 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, ISR62046; ARC I2000SR INST, 03M74-02, ISR62046