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 Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2020

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 08d06-77, that has a similar product distributed in the us, list number 08d06-41.

Event Description

The customer observed a false nonreactive architect (b)(6) tp result for one patient.The following data was provided (<1.00 s/co is nonreactive, >/=1.00 s/co is reactive): sample id (b)(6) initial result, on (b)(6) 2020, was 0.97 s/co.This sample was reactive when tested with other platforms, including with tppa testing.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false nonreactive architect syphilis tp results 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 testing of retained reagent kits of the complaint lot number.Trending review determined no related trend for the issue for the product.Return testing was not completed, as returns were not available.Sensitivity testing was performed using an in-house retained kit of lot 12693be01, stored at the recommended storage condition.All specifications were met, and no false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of architect syphilis tp, lot number 12693be01, was identified.

Manufacturer Narrative

Upon further review, section d4 - lot no updated from 12693be00 to 12693be01.

Manufacturer Narrative

Upon further review, section d4 - lot no updated from 12693be00 to 12693be01.

• 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
• MDR Report Key: 10788548
• MDR Text Key: 225990320
• Report Number: 3002809144-2020-01086
• 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,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2021
• Device Catalogue Number: 08D06-77
• Device Lot Number: 12693BE01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR50708; ARC I2000SR INST, 03M74-02, ISR50708; ARC I2000SR INST, 03M74-02, ISR50708