MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number 195-160

Device Problem Non Reproducible Results (4029)

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

Event Date 12/03/2021

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 a conflicting result with the binaxnow covid-19 antigen self test otc 2 test pack on a nasal swab sample.The initial test performed generated a positive result.Repeat testing was performed the following day on a nasal swab and generated a negative result.The consumer reported that he was symptomatic ten days prior to testing.Technical services (ts) advised to obtain confirmation testing.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 170055 with internal limit of detection (lod) positive quality control x3 devices and negative (blank) swabs x3 devices.All tests were valid and performed as expected with no conflicting results replicated.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 195-160 lot 170055 and device part number 195-430h / lot 168079.Quality control release testing met specifications with no conflicting results observed.The current overall incident rate for false positive patient results (confirmed and unconfirmed, conflicting results) for this specific lot based on the total quantity of devices manufactured for distribution is(b)(4).Based on the evidence available, it indicates that this device lot is performing within label claims.No further action is required.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue; however, it could possibly be related to issues including the self-test user performance, interpretation of the result, or the specific patient sample.

• Brand Name: BINAXNOW COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK
• Type of Device: LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 13119326
• MDR Text Key: 285715564
• Report Number: 1221359-2021-03917
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 01008118770114081722061910170055
• 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: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/19/2022
• Device Catalogue Number: 195-160
• Device Lot Number: 170055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2021
• 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
• Patient Sex: Male