MAUDE Adverse Event Report: SYPHILIS TREPONEMAL ANTIBODY TEST (MHA-TP); TEST, DONOR, SYPHILIS, ANTIGENS, TREPONEMAL

Device Problem Cross Reactivity (1137)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Greetings, i am a long time (many years) blood donor and one blood, the donor organization here in (b)(6), routinely tests my donated blood.My donation was rejected in the past few months due to a (b)(6) syphilis test and i had another sample taken recently to confirm if that test was (b)(6).It also came back (b)(6).I have donated for years and have not had a (b)(6) syphilis test in the past, but i did recently have the three shot regimen of moderna's covid vaccines.I looked at the internet and found that you have recently sent an advisory about a cross reaction between the covid vaccine and an rpr syphilis test: https://www.Fda.Gov/medical-devices/letters-health-careproviders/ possible-false-rpr-reactivity-bioplex-2200-syphilis-total-rpr-test-kit-following-covid-19-vaccine i believe that this may also occur with the test used on my blood (syphilis treponemal antibody test (mha-tp) run by creative testing solutions, tempe, az).I was (b)(6) for the captia syphilis g eia.I thought you should be aware of this issue and may want to investigate.Blood donor organizations may be turning away acceptable donors due to cross reactivity in the syphilis tests.If you would like more information or would like to discuss this more, feel free to contact me.All the best, (b)(6).Fda safety report id #:(b)(4).

• Brand Name: SYPHILIS TREPONEMAL ANTIBODY TEST (MHA-TP)
• Type of Device: TEST, DONOR, SYPHILIS, ANTIGENS, TREPONEMAL
• MDR Report Key: 13472014
• MDR Text Key: 285335573
• Report Number: MW5107223
• Device Sequence Number: 1
• Product Code: MYR
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White