MAUDE Adverse Event Report: QUIDEL CORP SOFIA 2 ANTIGEN TESTING KIT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 142824

Device Problems Crack (1135); Incorrect, Inadequate or Imprecise Result or Readings (1535); Difficult to Open or Remove Packaging Material (2922)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2020

Event Type  malfunction  

Event Description

False positives on 7 patients using lot#142824 for these antigen tests.The pcrs that were completed by the cdc who was here working side by side us came back negative.This lot had some noticeable problems such as the saline droppers were cracking when being used and the aluminum package the testing cassettes came in were much more difficult to tear open then the thousands of others we have used here.We collaborated with the cdc and are testing about 2000 students and staff each work week here at (b)(6).There was a group of false positive that came out like rapid fire one after the other for us to know the something was wrong.Together we narrowed it down to that particular lot.Fda safety report id# (b)(4).

• Brand Name: SOFIA 2 ANTIGEN TESTING KIT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP ; san diego CA 92121
• MDR Report Key: 10747475
• MDR Text Key: 213662629
• Report Number: MW5097476
• Device Sequence Number: 1
• Product Code: QKP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/26/2020
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 142824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR