MAUDE Adverse Event Report: CURATIVE, INC. CURATIVE (VECTOR ONE); REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Device Problems Improper or Incorrect Procedure or Method (2017); Ambient Temperature Problem (2878)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2021

Event Type  malfunction  

Event Description

[curative qpcr-rt covid-19 test] use for covid-19 under emergency use authorization (eua): per our training, these tests cannot exceed 104¿f.They are being stored in a metal mobile storage where temps have exceeded this temperature multiple times.About 8,000 to 10,000 tests at our location have been impacted yet we continue to use these tests to test for covid-19.Leadership is well aware of this and have the text messages to prove it.Nothing has been done to correct the issue thus the consistent heat (according to our training) would have damaged these tests by now.Fda safety report id# (b)(4).

• Brand Name: CURATIVE (VECTOR ONE)
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): CURATIVE, INC. ; 430 s cataract ave; san dimas CA 91773
• MDR Report Key: 11998836
• MDR Text Key: 256456620
• Report Number: MW5101872
• Device Sequence Number: 1
• Product Code: QJR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• 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