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

Model Number N/A

Device Problem Unraveled Material (1664)

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

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

In order to identify the true root casuse of this allegation, access bio would need to further communicate with the complainant to rule out potential root causes.However, in the absence of information from the customer it would be difficult to rule out potential root causes identified below.1.Complainant might misinterpret test result 2.Complainant might not follow the instructions for use (ifu) 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.Operating test outsdie of storage conditions f.Excessive buffer application to sample well of test device 3.Complainant might not use the test in accordance with its intended use a.Taking high doses of biotin (>10 mg per day) 4.13% of false negative results are expected based on perfromance characteristics claimed for this test (87% ppa) 5.Tests might be exposed to extreme environmental conitions during storage 6.Rapid test that she performed might yield false negative result access bio will continue to monitor further complaints through our data trending programs and take further actions based on identified valid trends.

Event Description

On (b)(6) 2023, accessbio received a complaint from an email regarding false negative.The complainant tested on care start product on (b)(6) 2023 & on (b)(6) 2023 and tested negative; however, coronavirus antigen ia rapid test performed 1 hour after on (b)(6)2023 came up positive.

• Brand Name: CARESTART COVID-19 ANTIGEN HOME TEST
• Type of Device: COVID-19 ANTIGEN SELF-TEST
• Manufacturer (Section D): ACCESS BIO INCORPORATE; 65 clyde rd suite a; somerset NJ 08873
• Manufacturer Contact: howard luu ; 65 clyde road, suite a; somerset, NJ 08873 ; 7328734040
• MDR Report Key: 18558136
• MDR Text Key: 333464257
• Report Number: 3003966368-2023-00143
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210314
• 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: 12/21/2023

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 Operator: Lay User/Patient
• Device Expiration Date: 02/01/2024
• Device Model Number: N/A
• Device Catalogue Number: RCPM-00271
• Device Lot Number: CP22L06
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic