MAUDE Adverse Event Report: COVID TEST; REAGENT, CORONAVIRUS SEROLOGICAL

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

Patient Problem Virus (2136)

Event Date 06/02/2020

Event Type  malfunction  

Event Description

I was charged (b)(6) cash by my dr to have a covid antibody test done.They drew a blood sample at my house and brought it to their lab where i understand a drop of it placed on a cassette and told me i was negative.Eventually i went to (b)(6) and found out i had covid and several of my family were exposed.Other patients of this md paid as much as (b)(6) for this test.Kits were provided by (b)(6) to my md for (b)(6).Dr.Charged me for additional lab work from my blood.I understand test no longer available through that vendor; (b)(6).Fda safety report id# (b)(4).

• Brand Name: COVID TEST
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• MDR Report Key: 10211538
• MDR Text Key: 197139675
• Report Number: MW5095266
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/01/2021
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 91