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

Catalog Number 195-160

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 05/01/2022

Event Type  malfunction  

Event Description

The consumer reported that the nasal swab contained in the binaxnow covid-19 antigen self-test had a yellow tip.The consumer continued with the test and used the nasal swab to swab both nostrils.The consumer reported that after using the swab that their nostrils burned a little and did not seek medical attention.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

This supplemental report is being submitted to retract the previous initial mdr report for a nasal swab with yellow tip / presence of foreign material on swab while both nostrils were swabbed.Further case review determined that consumer was not alleging any foreign material or a product malfunction.However, consumer was ensuring the use of yellow colored swabs are normal and manufactured according to the product specifications.Furthermore, there is no medical intervention or serious injury occurred while using our binaxnow covid-19 self-test.

• Brand Name: BINAXNOW COVID-19 ANTIGEN 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 ; 6613888803
• MDR Report Key: 14732691
• MDR Text Key: 301497111
• Report Number: 1221359-2022-02938
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081723042110188760
• 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: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Device Lot Number: 188760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/17/2022
• Supplement Dates Manufacturer Received: 08/02/2022
• Supplement Dates FDA Received: 08/09/2022
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White