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

Lot Number 140709

Device Problems Shipping Damage or Problem (1570); Expiration Date Error (2528)

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

Event Date 09/22/2021

Event Type  malfunction  

Event Description

Patient called to report an expiration issue related to binaxnow covid-19 tests he purchased from (b)(6).Patient stated he placed the order for six tests on (b)(6) 2021, received them on (b)(6) 2021, and noticed they had an expiration date of 9-28-2021, which was only 6 days after receiving the tests.Patient said he called the company and was told they would send him more tests.Patient stated he never received more tests so he called again and was told the expiration date could be extended 3 months.Patient said he never did receive replacement tests, and the extended expiration did not help him as he was intending to use them for travel after the 3 month extended expiration date.

• Brand Name: BINAXNOW COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 12908443
• MDR Text Key: 281583748
• Report Number: MW5105674
• Device Sequence Number: 6
• 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: 11/30/2021
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 140709
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male