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

Model Number KIT-01-D

Device Problems False Positive Result (1227); Patient Device Interaction Problem (4001)

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

Event Date 05/05/2021

Event Type  malfunction  

Event Description

The patient called in saying that they received a false positive because when they took their test, they put the swab straight into the sample tube without swabbing their mouth.They want to know why they received a positive.

Manufacturer Narrative

Fda has now requested that all suspected and alleged false positive and false negative complaints be reported retrospectively.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 drive-thru and dat (curative patient databases) that the patient received one positive curative test on (b)(6) 2021 at 7:14pm.The patient's test sample (barcode #(b)(4)) was collected (b)(6) 2021 at 4:34pm and later resulted in a viral ct value of 38.1, which falls in the repeat range.The patient's test sample was then repeated for a second time and resulted in a viral ct value of 33.4, indicating a positive result.No corrections were made to this test report upon release to the patient.The patient's sample was located on (b)(4).Testing for the patient's sample started on (b)(6) 2021 at 2:08pm and the result for this test was released on (b)(6) 2021 at 7:14pm as positive.Per the clinical lab's investigation, results for the patient's sample were reported correctly and any contamination to the patient's sample was ruled out based on evaluation of the controls and empty wells in the plate.The patient's sample was located on (b)(4) at position d8.(b)(4) contained several empty wells at positions a10, a11, a12, b10, b11, b12, c10, c11, c12, d9, d10, d11, d12, e9, e10, e11, e12, f9, f10, f11, f12, g9, g10, g11, g12, h9, h10, h11, h12 - all of which displayed zero human and viral amplification.Therefore, curative has no reason to believe that the patient's sample was contaminated by any of the surrounding positive samples.(b)(4) was created using the hamilton method in plating ((b)(4)), extracted using the king fisher method (s(b)(4), reagent lot #s: 18753300, bbd 1886100, bbd 2-propanol, shbm8301, wash wbe 18723200, wash wbe 2-propanol shbm8301, ethanol shbm5942, elution 201712), and prepared for qpcr using the integra method ((b)(4)) and a mastermix from batch 3.Moreover, the reagents used to test the patient's sample were in specification, not expired, passed qc and the floating blank was in the correct position.A floating blank is a well on the 96-well pcr plate that is intentionally left blank (that has no specimen) that is used to help verify the correct position of the plate in the pcr result software when the plate is undergoing review.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 positive.The result of the investigation clearly showed a true positive result.

• 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 91772-2902 ; 6262729019
• MDR Report Key: 12775940
• MDR Text Key: 281291081
• Report Number: 3016605234-2021-00049
• 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: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/11/2022
• Device Model Number: KIT-01-D
• Device Lot Number: VTO10036604
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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: 22 YR
• Patient Sex: Male