MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT SYPHILIS TP

Catalog Number 08D06-77

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided by the customer.This report is being filed on an international product, list number 8d06-39 that has a similar product distributed in the us, list number 8d06-41.

Event Description

The customer reported false nonreactive architect syphilis results on one patient.The results provided were: on 16dec2019 colloidal gold was positive / sid401 architect =0.75s/co (<1.00s/co = nonreactive) / tppa = positive / on 19dec2019 retest sample on architect = 0.73s/co.There was no reported impact to patient management.

Manufacturer Narrative

Corrected information for section d2 product code from incorrect mtn to correct lip.

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 trending data, a review of product quality history, and a review of product labeling.Ticket searches determined that there is normal complaint activity for the lot and the tracking and trending report review determined that there are no related trends.Return testing was not completed as returns were not available.Manufacturing documentation was reviewed and did not identify any issues.A retained reagent kit of lot number 07415be00, which contains the same bulk material as lot 07415be01, 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 non-reactive results were obtained.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified for the list number 08d06-77, lot 07415be01.

Manufacturer Narrative

Correction to section d.Suspect medical device 4.Catalog # from 08d06-39 to 08d06-77, lot # from 07415be00 to 07415be01, udi from (b)(4) to (b)(4).

• 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: 9565145
• MDR Text Key: 190178681
• Report Number: 3002809144-2020-00023
• Device Sequence Number: 1
• Product Code: LIP
• 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,Followup
• Report Date: 06/16/2020

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 Expiration Date: 07/08/2020
• Device Catalogue Number: 08D06-77
• Device Lot Number: 07415BE01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 01/10/2020; 03/04/2020; 06/15/2020
• Supplement Dates FDA Received: 01/31/2020; 03/05/2020; 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER,; ARCHITECT I2000SR ANALYZER,; ARCHITECT I2000SR ANALYZER, LN 03M74-02,; ARCHITECT I2000SR ANALYZER, LN 03M74-02,; LN 03M74-02, SERIAL # (B)(6); LN 03M74-02, SERIAL # (B)(6); SERIAL # (B)(6); SERIAL # (B)(6)
• Patient Age: 48 YR