MAUDE Adverse Event Report: ABBOTT MOLECULAR INC. ABBOTT MOLECULAR; ABBOTT BINAXNOW COVID-19 ANTIGEN TEST

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2022

Event Type  malfunction  

Event Description

See attached - mw5107946.

Manufacturer Narrative

This mdr submission is in response to the medwatch letter mw5107946 that was received by curative on 3/21/2022.Upon reviewing medwatch mw5107946, the complainant claims that the employee who administered the abbott binaxnow covid-19 antigen test "stabbed too deep" while swabbing the complainant's right nostril.The complainant states that their right nostril started "running clear water" immediately after.While driving home from completing the test, the complainant claims that her left nostril started running as well.The complainant also states that after taking the test, she became excessively tired for the rest of the day.The complainant states that the next morning, she woke up with migraines and threw up upon drinking coffee.The complainant states having to take pain killers to ease the pain of the migraines.The complainant states that it took 2 to 3 days to finally start feeling normal again.From our preliminary investigation, it was found in curative's patient database that the complainant tested on (b)(6) 2022 at 9:14am pst and received their result on (b)(6) 2022 at 9:37am pst.The patient received a negative test result.No corrections were made upon the release of the results.In addition, the field operations team was consulted to identify the curative employee who administered this particular test to the patient.Once identified, said curative employee was asked if they recalled the incident and to provide as much details as possible about this particular test.The curative employee was identified.Although the employee does recall the time period in which this test was performed, neither the employee nor the site leads and staff received any complaints from patients on that day, (b)(6) 2022.However, as a corrective action, the curative employee responsible for administering the complainant's test has attended a re-training on (b)(6) 2022 specifically related to administering the abbott binaxnow covid-19 antigen test.In conclusion, the results of the investigation show that since the test site did not receive any complaints regarding this incident immediately after the patient tested on (b)(6) 2022, the test site personnel were unable to recall this particular incident.Of note, the description given by the complainant of vomiting, fatigue, migraines does not seem consistent with medical sequelae after a nasal swab.However, curative takes patient complaints very seriously and have ensured this particular curative employee attended a re-training on proper procedures when administering the abbott binaxnow covid-19 antigen test on (b)(6) 2022.

• Brand Name: ABBOTT MOLECULAR
• Type of Device: ABBOTT BINAXNOW COVID-19 ANTIGEN TEST
• Manufacturer (Section D): ABBOTT MOLECULAR INC.; 1300 e touhy ave; des plains IL 60018
• Manufacturer (Section G): ABBOTT MOLECULAR INC.; 1300 e touhy ave; des plains IL 60018
• Manufacturer Contact: albert chianello ; 1300 e touhy ave; des plains, IL 60018 ; 2246676100
• MDR Report Key: 14047902
• MDR Text Key: 294832189
• Report Number: 3016605234-2022-00002
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 55 YR
• Patient Sex: Female