MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 HOME TEST; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number 195-160

Device Problem False Negative Result (1225)

Patient Problem Cough (4457)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported unconfirmed false negative result with the binax now covid-19 antigen self test.The customer stated the test kit generated negative results.The customer stated patient was symptomatic with a cough.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

It was initially reported that the customer experienced an unconfirmed false negative result.Upon further review, this should not have been reported as there was no allegation of a false negative result.The customer was inquiring about the specificity of the test with new variants and was provided with information.While the patient was experiencing a cough and received a negative covid-19 result, the customer was inquring if the negative result covered different variants.

• Brand Name: BINAX NOW COVID-19 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: naissa bogard ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 12312095
• MDR Text Key: 266165360
• Report Number: 1221359-2021-02251
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA202537
• 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: 02/21/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 02/21/2022
• 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