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U.S. Department of Health and Human Services

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

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Diagnostic Direct, LLC SYPHILIS HEALTH CHECK ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM Back to Search Results
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).
 
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Brand NameSYPHILIS HEALTH CHECK
Type of DeviceENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
Manufacturer (Section D)
Diagnostic Direct, LLC
359 96th st suit 303
sone harbor NJ 08247
MDR Report Key12540027
MDR Text Key273786677
Report NumberMW5104221
Device Sequence Number4
Product Code LIP
Reporter Country CodeUS
Number of Events Reported1
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 Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/27/2021 Patient Sequence Number: 1
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