MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT SYPHILIS TP

Catalog Number 08D06-77

Device Problem False Positive Result (1227)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The patient with the initial (b)(6) result is a (b)(6) year old male patient.No additional patient details are available other than gender for the patients wife.All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed for an adverse event potentially related to an international product, (b)(6) list 08d06-77 that has a similar product distributed in the us, list number 08d06-31/41.

Event Description

The customer reported a (b)(6) result for a (b)(6)-year old male patient on (b)(6) 2019, when processing on the architect i2000sr.The initial result was 2.48 s/co.Additional testing with trust method, generated a result of (b)(6).In (b)(6) 2019, testing with rpr and tppa was (b)(6) and additional (b)(6) testing at other hospitals was also (b)(6).As the patient was concerned with the (b)(6) results, he had his wife tested for (b)(6) and her results were (b)(6).In (b)(6) 2019, the patients wife became pregnant.However, the patient stated he and his wife were worried that (b)(6) would affect the fetus and the couple chose to have an abortion.No data is available regarding any clinical input into the decision to terminate the pregnancy.Other information such as relevant medical history, comorbidities or risk factors leading to termination of pregnancy is unknown at this time.

Manufacturer Narrative

This report is being submitted to correct the date in date received by manufacturer to 24nov2019, from 10dec2019 which was submitted in the initial mdr report for this event.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, a search for similar complaints, a review of tracking and trending data, testing with a retained reagent kit, and a review of product labeling.Ticket searches determined normal complaint activity for the likely cause lot and tracking and trending review did not identify any trends.A retained reagent kit of lot number 01118be01 was tested in a specificity setup, including additional replicates of a specificity panel.Results of this setup did not implicate that the performance regarding specificity of the lot is negatively impacted.No false reactive results were obtained.No systemic issue was identified.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• Brand Name: ARCHITECT SYPHILIS TP
• Type of Device: SYPHILIS
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9467234
• MDR Text Key: 176775287
• Report Number: 3002809144-2019-01060
• Device Sequence Number: 1
• Product Code: MTN
• Combination Product (y/n): N
• 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: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2020
• Device Catalogue Number: 08D06-77
• Device Lot Number: 01118BE01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 11/24/2019; 02/10/2020
• Supplement Dates FDA Received: 12/16/2019; 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER.; ARCHITECT I2000SR, LIST 03M74-02.; LIST 03M74-02 SERIAL (B)(4).; SERIAL (B)(4).
• Patient Outcome(s): Disability