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

Catalog Number 195-100

Device Problem Use of Device Problem (1670)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 10/08/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported a procedural error with binaxnow covid-19 home test on (b)(6) 2021.The consumer put the reagent on the swab , and inserted in the nostrils.The consumer did not provide if they were asymptomatic or symptomatic.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

A product deficiency was not reported or found.Technical service provided the reagent safety data sheet to the consumer.A supplemental report will be provided if any additional is obtained.

• Brand Name: BINAXNOW COVID-19 ANTIGEN CARD HOME 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: 14244689
• MDR Text Key: 290412058
• Report Number: 1221359-2022-02179
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011330
• UDI-Public: 01008118770113301721092210140869
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA203107
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-100
• Device Lot Number: 140869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2022
• 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