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 Problems False Negative Result (1225); False Positive Result (1227)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Please refer to related mfr report numbers: 1221359-2022-03185 and 1221359-2022-03190.

Event Description

The customer reported four (4) false negative results with the id now covid-19 assay performed between (b)(6) 2022, with one test being taken on (b)(6) 2022 after the pcr test was performed.This report is tests one (1) of four (4).Pcr testing was performed on (b)(6) 2022 and generated a positive result.No additional information regarding outcome was provided.

Event Description

Correction: false negative results was with the binaxnow covid-19 antigen self test not id now covid-19.

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 186666 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 test kit part number 195-160/ lot 186666 and device part number 195-430h/ lot 173829.The lot met the required release specifications.The current overall incident rate for false negative patient results (confirmed and unconfirmed, conflicting results) for this specific lot based on the total quantity of devices manufactured for distribution is 0.001%.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue however a possible assignable root cause is patient sample interference.Substances in the sample itself may have interfered with the reaction.Please refer to related mfr report numbers: 1221359-2022-03185, 1221359-2022-03188 through 1221359-2022-03190.

Manufacturer Narrative

This report is being submitted to correct the h6 "medical device problem code" listed in the report.Please see h6 of this report for the corrected code.

• 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,
• MDR Report Key: 14830394
• MDR Text Key: 295062057
• Report Number: 1221359-2022-03188
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081723031610186666
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• 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: 186666
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2022
• 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 Sex: Female
• Patient Weight: 91 KG