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 Delivered as Unsterile Product (1421)

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

Event Date 12/25/2021

Event Type  malfunction  

Manufacturer Narrative

This investigation is still in progress.Once the investigation is completed, a supplemental report will be provided.

Event Description

The consumer reported that the binaxnow covid-19 antigen self-test swab packaging contained a "hair inside the wrapper." the date of this reported event is unknown.No adverse patient effects were reported.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

Correction: h4.Additional: d4.Investigation report: testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 173463 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for kit part number 195-160 / lot 173463 and device part number 195-430h / lot 170543.The lot met the required release specifications.The current overall incident rate for foreign objects for this specific lot 173463 based on the total quantity of kits manufactured for distribution is 0.0003% abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue, however based on the information provided by the customer it appeared related to known potential manufacturing defects.

• 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: 13291737
• MDR Text Key: 284700131
• Report Number: 1221359-2022-00318
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011415
• UDI-Public: 01008118770114151722101210173463
• 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: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/12/2022
• Device Catalogue Number: 195-160
• Device Lot Number: 173463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/29/2021
• 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