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 Problem No Apparent Adverse Event (3189)

Patient Problems Abdominal Pain (1685); Nausea (1970); Dizziness (2194)

Event Date 11/13/2023

Event Type  malfunction  

Event Description

The consumer reported accidental reagent exposure to her face and mouth with a binaxnow covid-19 antigen self-test on (b)(6) 2023.Per the consumer, the reagent solution splashed on her face and mouth at nighttime.The consumer felt nauseous, dizzy, and experienced a little stomach pain when she woke up.Although requested, no additional information was provided.

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single use; device discarded.

Event Description

The consumer reported accidental reagent exposure to her face and mouth with a binaxnow covid-19 antigen self-test on (b)(6)2023.Per the consumer, the reagent solution splashed on her face and mouth at nighttime.The consumer felt nauseous, dizzy, and experienced a little stomach pain when she woke up.Although requested, no additional information was provided.

Manufacturer Narrative

A product deficiency was not reported or found.Technical services was unable to send the customer the reagent safety data sheet, as there was no contact information given.The reported health status is anticipated in nature and severity for binaxnow covid-19 ag card risk documentation.H3 other text : single use; device discarded.

• 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: 18252161
• MDR Text Key: 330014928
• Report Number: 1221359-2023-01697
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 00811877011408
• Combination Product (y/n): N
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2023
• 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 Outcome(s): Other
• Patient Sex: Female