MAUDE Adverse Event Report: ACCESS BIO INCORPORATE CARESTART COVID-19 ANTIGEN; COVID-19 ANTIGEN TEST

Catalog Number RCHM-02071

Device Problems False Negative Result (1225); Obstruction of Flow (2423); No Apparent Adverse Event (3189)

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

Event Date 12/18/2020

Event Type  malfunction  

Event Description

The customer reported on (b)(6) 2020, suspected two (2) false negative results from a rapid result covid test system for an unknown patient.The first carestart sars-cov-2 antigen test was performed on (b)(6) 2020, which gave a negative result, followed by a second consecutive test with the same (negative) result.The patient was sent home from work and reported testing covid positive with a pcr test.After getting notified by the patient of a positive pcr test, the customer performed the quality control steps as instructed on the ifu (instruction for use).The customer performed the quality control on 3 of the 5 boxes and the test failed.When access bio followed up with the customer on (b)(6) 2020 to better understand the circumstances for the test, the customer stated that the color intensity was very faint on some quality control samples.Most samples did not advance the reagent as if there was a blockage.The customer also shared that the test kits were stored at room temperature and later the customer shipped the unused samples to access bio for further evaluation.No adverse patient effects were reported.

Manufacturer Narrative

In order to identify the true root cause of this complaint, the technical support team at access bio tested the retained product of lot# ch20l03 which provided acceptable results for both positive and negative samples.The technical support team at access bio also tested the returned samples on (b)(6) 2021, and it did show valid results against both positive and negative qc panels.In addition, both positive and negative external control swabs showed the corresponding control and test lines.Based on the information reviewed and evaluated, a potential cause of the false negative can be the result of user error that would have caused the reagent to not fully advance through the test trip.The likely reasons for this could be: 1.The application of a highly viscous sample and/or 2.Excessive sampling such sampling can affect the migration of reagent through the strip resulting in very faint color intensity or no color at all as reported by the customer.In addition to these, the other possible reasons that could not be completely ruled out.For this case include: 1.The customer might misinterpret test results.2.The customer might not follow the instructions for use (ifu) in any of the following way: a.Inadequate sample collection.B.Interpreting results before 10 minutes.C.Not performing test immediately after opening the test device in the pouch.D.Potential contact with foreign substances and household cleaning products during sample collection and testing.E.Excessive buffer application to sample well of test device.3.The customer might not have used the test in accordance with its intended use: a.Testing outside of the first 5 days of symptom onset.B.The patient might have taken high doses (>10 mg per day) of biotin before testing 4.6.25% of false negative results are expected based on performance characteristics claimed for this test (93.25% ppa).5.The pcr test might yield false positive results access bio will continue to monitor further complaints through our data trending programs and take further actions based on identified valid trends.

• Brand Name: CARESTART COVID-19 ANTIGEN
• Type of Device: COVID-19 ANTIGEN TEST
• Manufacturer (Section D): ACCESS BIO INCORPORATE; 65 clyde rd suite a; somerset NJ 08873
• Manufacturer Contact: david park ; 65 clyde rd suite a; somerset, NJ 08873 ; 7328734040
• MDR Report Key: 15441904
• MDR Text Key: 305986461
• Report Number: 3003966368-2022-00149
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA202625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: RCHM-02071
• Device Lot Number: CH20L03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2020
• 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