MAUDE Adverse Event Report: RAPID ANTIGEN TEST SALIXIUM; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 202110226

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem Insufficient Information (4580)

Event Date 07/13/2022

Event Type  malfunction  

Event Description

I was testing myself for covid as my husband had it.I used the "covid-19 rapid antigen test, saliva/nasal swab samples" kit by salixium, made in malaysia.After i put the swab in the tube, the first one didn't have enough liquid in it to test.The second one didn't have enough liquid either before i put the swab in the tube.I have the third test unopened.It also doesn't have enough liquid.It is lot number 202110226, exp 2023/04, ref slxhb1-0621001.This product is distributed by (b)(4).Fda safety report id# (b)(4).

• Brand Name: RAPID ANTIGEN TEST SALIXIUM
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 15066859
• MDR Text Key: 296299115
• Report Number: MW5110962
• Device Sequence Number: 3
• Product Code: QKP
• 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: 07/18/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/30/2023
• Device Lot Number: 202110226
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White