MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 204854

Patient Problem Malaise (2359)

Event Type  malfunction  

Event Description

Patient was not feeling well so she took a covid test.As she was waiting for the results, she noticed the control line is blue but the sample is pink/purple.She also states the strips are expired but has an extended expiration date.Original expirate date 08/05/2023, extended expiration date 03/05/2024.

• Brand Name: BINAXNOW
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 18345853
• MDR Text Key: 330868807
• Report Number: MW5149312
• 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: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/05/2024
• Device Lot Number: 204854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female