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
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This investigation is still in progress.Once the investigation is completed, a supplemental report will be provided.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1221359-2022-00318
• Device Sequence Number: 11823161
• Product Code: QKP
• UDI-Device Identifier: 00811877011415
• UDI-Public: 01008118770114151722101210173463
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EUA210264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2021
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown