MAUDE Adverse Event Report: TESTING FOR COVID TITERS, VACCINE; REAGENT, CORONAVIRUS SEROLOGICAL

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Cognitive Changes (2551); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

I was told i had no antibodies to the covid vaccine (moderna), after my doctor asked for both antibody tests, those that come from the virus, and the others that develop from the vaccine.(b)(6) didn't do the correct test, and just reported negative.Led to much confusion and worry.Seems they only tested for virus antibodies, which i never had.They did not test for the vaccine antibodies, which i should have shown, and told me i had none.Went on to another clinic and had a high level of vaccine titers.This complaint is of (b)(6).Caused much stress due to incorrect testing, therefore telling me i had no immunity to covid 19.(b)(6) administered the test.Fda safety report id# (b)(4).

• Brand Name: TESTING FOR COVID TITERS, VACCINE
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• MDR Report Key: 12406000
• MDR Text Key: 269547623
• Report Number: MW5103619
• Device Sequence Number: 1
• Product Code: QKO
• 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: 08/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 61