MAUDE Adverse Event Report: ACCESS BIO INCORPORATE CARESTART 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 11/18/2023

Event Type  malfunction  

Manufacturer Narrative

Potential root causes for false positive were identified and listed below: the technical support team at access bio tested the returned lot# ch23f01 which provided acceptable results for both positive and negative samples.Moreover, the support team at accessbio also ran clinical study by testing on 5 randomly different employees, the result came out fine without any issues.1.Complainant might misinterpret test results.2.Complainant might not follow the instructions for use (ifu) a.Inadequate sample collection (excess blood or mucus on swab).B.Interpreting result after 15 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.Operating test outside of storage conditions.F.Excessive buffer application to sample well of test device.3.0.68% of false positive results are expected based on performance characteristics claimed for this test (npa: 99.32%) access bio will continue monitor further complaints through our data trending program and take further actions based on identified valid trends.

Event Description

The subject #2 of 2 that (b)(6) reported as receiving false positive (pink line in the test area) on (b)(6) 2023.On (b)(6) 2023, test was repeated again with the same lot and same result was obtained.

• Brand Name: CARESTART COVID-19 ANTIGEN TEST
• Type of Device: COVID-19 ANTIGEN TEST
• Manufacturer (Section D): ACCESS BIO INCORPORATE; 65 clyde rd suite a; somerset NJ 08873
• MDR Report Key: 18413546
• MDR Text Key: 331758722
• Report Number: 3003966368-2023-00006
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RCHM-02071
• Device Lot Number: CH23F01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2021
• 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