MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC BINAXNOW COVID-19 SELF-TEST; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number 195-160

Device Problem Use of Device Problem (1670)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 04/01/2022

Event Type  Injury  

Event Description

The consumer reported on reagent added on nose, with the binaxnow covid-19 ag self-test on (b)(6) 2022.The consumer was confused about the steps she thought that she needs to put in the reagent on her nose but when she read it again it supposed to be on the test card on the top hole and the swab should be used for her nostril.The consumer stated that she was experiencing irritation she did washed it as soon she experience irritation and called up her health care provider asking what can be the medications.No additional patient information, including treatment and outcome, was provided.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be provided after completion.

Manufacturer Narrative

A product deficiency was not reported or found.Technical service provided the safety data sheet (sds).

• Brand Name: BINAXNOW COVID-19 SELF-TEST
• Type of Device: LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 14210038
• MDR Text Key: 290085386
• Report Number: 1221359-2022-02171
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081723020410181425
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/04/2023
• Device Catalogue Number: 195-160
• Device Lot Number: 181425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian