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

Catalog Number RCHM-02071

Device Problems False Positive Result (1227); Output Problem (3005); No Apparent Adverse Event (3189)

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

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

As the device was not returned to the manufacturer, the technical support team at access bio tested the retained product of lot# ch20m01 which provided acceptable results for both positive and negative samples.Further, access bio would need more information from the customer to identify the true root cause of this complaint.However, in the absence of information from the customer, it would be difficult to rule out the following potential root causes: the customer might misinterpret test results the customer might not follow the instructions for use (ifu) excess blood or mucus on the swab specimen may interfere with the test performance and may yield a false-positive result not performing test immediately after opening the test device in the pouch potential contact with foreign substances and household cleaning products during sample collection and testing.Operating test outside of storage conditions excessive buffer application to sample well of the test device tests might be exposed to extreme environmental conditions during storage the pcr test might yield a false-negative result 0.68% of false positive results are expected based on performance characteristic claimed for this test (npa: 99.32%) access bio will continue to monitor further complaints through our data trending programs and take further actions based on identified valid trends.

Event Description

The customer reported on (b)(6) 2021 a suspected false positive result from a rapid result covid test system for multiple (number unknown) unknown patients.The date of performing carestart sars-cov-2 antigen tests was unknown.All tests gave a suspected positive result.The customer stated that all false positives came from a single lot where many test devices showed a faint gray line and not the usual blue line normally seen in the case of positive samples corresponding to the test (t) region in the result window of the test device.The patients reported taking a pcr test after and obtained a negative result (date of test not provided).Access bio followed up two times on january 14, 2021 and december 15, 2021 to better understand the facts and circumstances for the tests.The customer did not share any details regarding product handling practices and quality control results.No adverse patient effects were reported.

• 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: 15441920
• MDR Text Key: 306275125
• Report Number: 3003966368-2022-00153
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: RCHM-02071
• Device Lot Number: CH20M01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• 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