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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Virus (2136)

Event Date 06/18/2020

Event Type  malfunction  

Event Description

My husband tested positive for the covid-19 and i received an assumed positive from a nurse because i had more symptoms than he did.We wanted to donate plasma and were told we needed an antibody test.We took the antibody test and both received negative results.Fda safety report id # (b)(4).

• Brand Name: COVID ANTIBODY TEST
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• MDR Report Key: 10188697
• MDR Text Key: 196399573
• Report Number: MW5095156
• 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: 06/19/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 66