MAUDE Adverse Event Report: Diagnostic Direct, LLC SYPHILIS HEALTH CHECK; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 05/25/2021

Event Type  malfunction  

Event Description

Hello, i work as the prevention manager for the (b)(6) funded testing program.We work with local providers to provide (b)(6) testing to high risk populations.We recently (as of (b)(6) 2021) endorsed our programs using rapid (b)(6) tests- the (b)(6) health check manufactured by (b)(6) waived community based testing activities.Soon after launching this testing we had a high number of false positive or suspected false positive tests in our program.Our testing partners, (b)(6) center and (b)(6) family planning have reported running 38 rapid (b)(6) tests on patients and 9 of those came back positive.Of those 9 positive tests, 7 were negative on confirmatory testing and 2 so far have been lost to follow up.This is a much higher than expected number of both positive and false positive tests for a relatively low (b)(6) prevalence state like (b)(6).We have reported these test results to the manufacturer on 7/7/2021.We have yet to hear back an explanation as to the reason for the high number of positive tests.I work for the health department and our contracted partners perform the testing and we do not do the testing ourselves but i wanted to report this information to the fda because the product's performance did not match what we would have expected, and i have heard of other negative reports about this product from other state std prevention programs.Fda safety report id# (b)(4).

• Brand Name: SYPHILIS HEALTH CHECK
• Type of Device: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Manufacturer (Section D): Diagnostic Direct, LLC; 359 96th st suit 303; sone harbor NJ 08247
• MDR Report Key: 12540027
• MDR Text Key: 273786677
• Report Number: MW5104221
• Device Sequence Number: 5
• Product Code: LIP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2021
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other