MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number 195-160

Device Problems No Apparent Adverse Event (3189); Non Reproducible Results (4029)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

Date of event provided in section b3 is an approximation, was not provided by consumer.The intake information required to enable further investigation, such as the kit¿s lot number, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints¿ trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.

Event Description

The consumer reported conflicting results with the binaxnow covid-19 antigen self-test performed on an unknown date.Per the consumer, the first test taken generated a positive result and the second test conducted and generated negative result.Confirmation testing was not performed.No additional patient information, including treatment and outcome, was provided.

Event Description

The consumer reported a positive result with the pcr at urgent care on (b)(6) 2023 and prescribed paxlovid as a result.The consumer proceeded with 2 binaxnow covid-19 antigen self-test performed on (b)(6) 2023 both generated positive results.Additionally, the consumer performed a third binaxnow covid-19 antigen self-test on (b)(6) 2024 and generated a negative result.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

Updated b5: customer provided additional information on 15apr2024 indicated that they performed one (1) pcr test and three (3) binaxnow tests.Abbott medical affair was consulted regarding the updated information, which provided that given the information that the patient tested negative after 3 days on paxlovid treatment, the negative results on (b)(6) 2024 is most likely truly reflecting the disease recovery progress rather than a false negative.  date of event provided in section b3 is an approximation, was not provided by consumer.The intake information required to enable further investigation, such as the kit¿s lot number, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints¿ trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST 2CT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 18998962
• MDR Text Key: 338885345
• Report Number: 1221359-2024-00304
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2024
• 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