MAUDE Adverse Event Report: RAPID COVID-19 ANTIBODY TEST QUIKPAC II COVID-19 IGG/IGM; REAGENT, CORONAVIRUS SEROLOGICAL

Lot Number 2006100

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2020

Event Type  malfunction  

Event Description

We believe that we were given a rapid covid-19 antibody test that shows on the fda "removed test list" it is the quikpac ii covid-19 igg/igm done on (b)(6) 2020 by (b)(6) in (b)(6).My husband and i were both tested using this specific test and charged a total of (b)(6) ((b)(6) per test).Fda safety report id# (b)(4).

• Brand Name: RAPID COVID-19 ANTIBODY TEST QUIKPAC II COVID-19 IGG/IGM
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• MDR Report Key: 10337824
• MDR Text Key: 201064067
• Report Number: MW5095752
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• 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: 07/24/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2006100
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1