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 False Positive Result (1227)

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

Event Date 12/02/2021

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 false positive result with the binaxnow covid-19 antigen self test otc, 2 test pack performed on (b)(6) 2021.Sample type was not provided by the consumer.The consumer obtained a second covid-19 test at a pharmacy which generated a negative result.The consumer did not mention the type of confirmation test used at the pharmacy.Technical services (ts) advised that the consumer should obtain a pcr test to confirm the results of the initial positive test.The consumer did not confirm if she was experiencing symptoms.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 158725 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.Number195-160 lot 158725, test base part number 195-430wl/lot 158725.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 158725 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue [add possible root cause as well].

• 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 ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 13119325
• MDR Text Key: 282977463
• Report Number: 1221359-2021-03915
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 10811877011290
• UDI-Public: 01108118770112901722040310158725
• 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: 03/10/2022

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: 04/03/2022
• Device Catalogue Number: 195-160
• Device Lot Number: 158725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2021
• 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: Female