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

Catalog Number 08D06-74

Device Problem False Negative Result (1225)

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

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The account generated (b)(6) architect syphilis results on a patient who tested (b)(6) with another method that was questioned by the physician.The patient tested architect syphilis(b)(6) of (b)(6) but non-specific trust method 1:8 (b)(6).The sample repeated architect syphilis (b)(6).The sample was sent to a reference lab for troubleshooting purposes with architect (serial (b)(4)) (b)(6).Result of (b)(6).The account does not know which result is correct for the patient.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

The ticket search by lot indicates that the reagent lot performs as expected for this product.The ticket trending review of complaint data for the likely cause list number does not identify any adverse trend.Labeling review concludes that the issue is adequately addressed.A review in the corrective and preventive actions (capa) system does not identify any non-conformances or deviations associated with the likely cause lot number and 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, showing that the lot generates the expected results.Based on all reviewed data, it is concluded that there is no general issue with the architect syphilis tp reagent lot identified in this complaint.No product deficiency 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12804937
• MDR Text Key: 282918020
• Report Number: 3002809144-2021-00647
• 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: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2022
• Device Catalogue Number: 08D06-74
• Device Lot Number: 28247BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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)(4), (B)(4).; ARC I2000SR INST, 03M74-02, (B)(4), (B)(4).