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 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 08d06-39 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 a (b)(6) architect syphilis tp result for a patient while running on the architect i2000sr analyzer.The following data was provided ((b)(6)): architect syphilis tp result = (b)(6), repeat result = (b)(6).Fluorescence method test = (b)(6).Tppa result = (b)(6).Trust result = (b)(6).There was no impact to patient management reported.No specific patient information was provided.

Manufacturer Narrative

The complaint investigation for false nonreactive architect syphilis tp result included a search for similar complaints, and the review of complaint text, trending data, labeling, device history records and in-house testing was completed.Return testing was not performed as returns were not available.Trending was reviewed and did not identify any trends for the product for the issue.In-house testing was done using a retained reagent kit of the complaint lot 25445be01 in a sensitivity setup.All controls met specifications and no false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.Device history records were reviewed and did not identify any non-conformances or deviations associated with the product and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency for architect syphilis tp, reagent lot 25445be01 was identified.

Manufacturer Narrative

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.Updated section d: suspect medical device: d4 - catalog no: initial: 08d06-39 / updated: 08d06-77; d4 - lot no: initial: 25445be00 / updated: 25445be01.

• 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: 12586098
• MDR Text Key: 278004266
• Report Number: 3002809144-2021-00593
• 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,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2022
• Device Catalogue Number: 08D06-77
• Device Lot Number: 25445BE01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2021
• 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).; ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).