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

Model Number KIT-01-D

Device Problem False Negative Result (1225)

Patient Problems Intraocular Pressure Increased (1937); Tinnitus (2103); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

This is a retrospective mdr submission.The (b)(4) did not provide clear guidance on mdr submission for unconfirmed false positive and false negative results.After clarification from the fda, all suspected and alleged false positive and false negative complaints received over 30 days, whether unconfirmed or confirmed, are being submitted via mdr retrospectively.From our preliminary investigation, it was found in (b)(6) (patient database) that the patient did receive one negative curative test result.The patient's test sample was collected on (b)(6) 2021 at 11:02 am cst.The result for this test was released on (b)(6) 2021 at 4:25 pm cst.The patient's sample resulted in a viral ct value of 'infinity' which falls under the negative range.No corrections were made to this test report upon release to the patient.Per the clinical lab's investigation, the sample was resulted correctly and any contamination to the patient's sample was ruled out.The patient's sample was located on plate-(b)(4) at position f3.Plate plate-(b)(4) was extracted by a cla (clinical lab assistant).Tecan 12 was used to extract plate-(b)(4) using filter plate lot fg3177, tcep lot 010921bab-tc2, wash buffer lot 010921bab-gb1 and elution buffer lot 201712.Moreover, (b)(4) was ran on plate 384 with other three plates.The reagents used to test the patient's sample were within specifications, not expired, passed qc and the floating blank was in the correct location.A floating blank is a well on a 96-well pcr plate that is intentionally left blank (has no specimen) that is used to help verify the correct orientation of the plate in the pcr result software when the plate is undergoing review.Master mix batch 244 was used for pcr.There was one sample next to f3 with a strong viral ct on 384 plate, which has higher potential to produce contamination during specimen processing.However, it can be confirmed that the patient's sample did not get contaminated as the patient's sample resulted in viral ct value of 'infinity'.The patient did not need to be contacted due to accurate results being reported to the patient.In conclusion, curative cannot confirm the patient's claim of false negative.The result of the investigation clearly showed a true negative result.The sample result will remain as a negative.Without the patient specimen left in the lab from the specimen collection date, curative is unable to retest the sample.Patient did not provide another sample for retest.

Event Description

Patient reached out to customer success asking about false negatives and informed the agent that they received their result and have symptoms.Informed agent that daughter and daughters boyfriend were both positive.Agent references that symptoms started the following "tuesday/wednesday".Patient communicates symptoms are "ocular pressure, ringing in ears, chest tightened.Lots of coughing and sniffles.".

• 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: 12054001
• MDR Text Key: 261115616
• Report Number: 3016605234-2021-00011
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/14/2021
• Device Model Number: KIT-01-D
• Device Lot Number: VTO10025432
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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
• Patient Age: 49 YR