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

Device Problem Output Problem (3005)

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

Event Date 01/09/2022

Event Type  malfunction  

Event Description

Complainant left a comment on (b)(6) website concerning potential false positive result.The comment was "tested positive, but actually turned out to be flu a and not covid".No adverse patient effects were reported.

Manufacturer Narrative

Possible root causes of suspected false positive result discovered through (b)(6)website review are following: 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.3.Complainant might not use the test in accordance with its intended use.A.Carestart home test had no cross reactivity against influenza a (michigan/45/2015) and influenza b(wisconsin/01/2010) but the test may have cross-reactivity with other variants of influenza.4.2% of false positive results are expected based on performance characteristics claimed for this test (98% npa).5.Complainant might be infected to both covid-19 and flu a.6.Viral titers of covid-19 may be decreased when complainant tested for covid-19 using other brand of kits.7.Additional covid-19 test that complainant performed for covid-19 using other brand might yield false negative results.8.Flu a diagnosis kit might have cross-reactivity against covid-19.In order to identify the true root cause of this allegation, access bio needs to further communicate with the complainant to rule out above potential root causes, but this would be difficult due to given limited information available and inability of access bio to investigate facts and circumstances.

• 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: david park ; 65 clyde rd suite a; somerset, NJ 08873 ; 7328734040
• MDR Report Key: 13595687
• MDR Text Key: 287206389
• Report Number: 3003966368-2022-00007
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• PMA/PMN Number: EUA210314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: No
• 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