MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINEXNOW COVID-19 ANTIGEN SELF TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 203265

Patient Problem Sore Throat (2396)

Event Date 01/06/2024

Event Type  Injury  

Event Description

Faulty abbott self covid-19 tests.Am an rn; 2 tests kits faulty.While waiting for result witnessed the liquid (drops) actually pushed the blue control line upward and never engulfed the blue line.Then the entire area was wet from the drops, no control or other lines evident at all, just a wet mess.Tried the second test from this box, performed it carefully and again as instructed- same results, pushed the blue line upward off of the cardboard and never saturated it.Used both covid -19 at home tests from one box, both did not work correctly.Use same brand last week from different box on my very sick symptomatic elderly "roommate", hers showed positive.We are taking precautions.Now i have odd symptom (very hoarse, sore throat) but need to care for her and need to know if i'm contagious to others.Cannot find anywhere to report faulty at home covid test kits.Please instruct where to report this.Thanks.This is an expired abbot binaxnow home test kit.Exp 7-2023.

• Brand Name: BINEXNOW COVID-19 ANTIGEN SELF TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 18483243
• MDR Text Key: 332641164
• Report Number: MW5150035
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/19/2023
• Device Lot Number: 203265
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White