MAUDE Adverse Event Report: CURATIVE INC. CURATIVE COLLECTION KIT; CURATIVE SARS-COV-2 ASSAY

Model Number KIT-01-D

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

Curative received the fda medwatch letter on july 1st, 2021.The complaint stated the following: "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 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." the complainant contact information was not provided in the complaint that was submitted to the fda.However, the complainant stated in the complaint that he or she completed a training where they learned that the curative collection kits cannot exceed the storage condition temperature limit of 104°f.Therefore, it can be deduced from the complaint that the complainant is/was a curative employee.In an effort to verify the complaint, qa held two meetings with the general managers for (b)(4), and the chief of staff for national field operations.In the meeting, qa asked the general managers and the chief of staff for national field operations to verify with their test site leads if the complaint stated in the fda medwatch letter was received and escalated to the leadership.The general managers and the chief of staff for national field operations followed up with their test site leads but could not verify the complaint as stated in the fda medwatch letter.It should be noted that there was high curative employee turnover due to test site closures that could have affected the ability to verify the complaint.The complainant claims that 8,000 to 10,000 curative collection kits were stored within metal mobile storage containers where temperatures have exceeded the storage condition limit of 104°f as stated on the kit label.Although curative could not verify the complaint, the manufacturer of the dna/rna shield solution (zymo research) confirmed that the zymo solution is stable for up to 6.7 weeks at 135.5°f (57.5°c) and up to 29 weeks at 104°f (40°c) based on a controlled stability study, (b)(4), completed by (b)(4) labs, an fda registered laboratory.In addition, curative has completed a stability study, stability of sars-cov-2 and human rna in oral fluid specimens stored in dna/rna shield at 41 ºc, that confirms that rna stored in dna/rna shield is stable for as long as 135 hours at temperatures up to 41ºc (105.8°f).Although curative could not verify the complaint, the stability data from zymo research and curative shows that the curative collection kit would be stable in elevated temperatures above 104°f and up to 135.5°f and would not impact the product performance and assay test results.In conclusion, the results of the investigation show that if the curative collection kits have been exposed to temperatures above 104°f, the stability studies show that the temperature excursion up to 135.5°f for 6.7 weeks would not impact the product performance and assay test results.

Event Description

Per fda medwatch letter (mw5101872), complainant stated the following: "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 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.".

• Brand Name: CURATIVE COLLECTION KIT
• Type of Device: CURATIVE SARS-COV-2 ASSAY
• Manufacturer (Section D): CURATIVE INC.; 430 s cataract ave; san dimas CA 91773 2902
• Manufacturer (Section G): VECTORONE; 21515 s western ave; torrance CA 90501
• Manufacturer Contact: carmelita torres ; 430 s cataract ave; san dimas, CA 91773-2902 ; 6262729019
• MDR Report Key: 12200002
• MDR Text Key: 264825709
• Report Number: 3016605234-2021-20003
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: KIT-01-D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1