MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD KIT 40T EUA; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number 195-000

Device Problem False Positive Result (1227)

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

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.

Event Description

The customer reported unconfirmed false positive results with the binaxnow covid-19 antigen card performed on or after on (b)(6) 2022 involving an unknown quantity of patients and one lot number: 218991.The test was performed with the kit swab on nasal samples.Confirmation testing was not performed.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.

Manufacturer Narrative

This supplemental report is being submitted to correct the previously reported event of unconfirmed false positive results.After new information was received, it was determined the customer did not experience or allege false positive results.The customer was inquiring about the faint line on the test cards.Therefore, this complaint is considered not reportable.The customer reported unconfirmed false positive results with the binaxnow covid-19 antigen card performed on or after (b)(6) 2022 involving an unknown quantity of patients and one lot number, 218991.The test was performed with the kit swab on nasal samples.Confirmation testing was not performed.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.H3 other text : device discarded; single-use device.

Event Description

10jan2023 vka: new information received on (b)(6) 2022 that customer did not experience or allege any positive results.The customer reported unconfirmed false positive results with the binaxnow covid-19 antigen card performed on or after (b)(6) 2022 involving an unknown quantity of patients and one lot number, 218991.The test was performed with the kit swab on nasal samples.Confirmation testing was not performed.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.

• Brand Name: BINAX NOW COVID-19 AG CARD KIT 40T EUA
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• 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: 16069829
• MDR Text Key: 308478901
• Report Number: 1221359-2022-10420
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 10811877011290
• UDI-Public: 10811877011290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA202537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2023
• Device Catalogue Number: 195-000
• Device Lot Number: 218991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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