MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW COVID-19 2.0 TEST KIT 24T JAPAN; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Catalog Number 192-000J

Device Problem Material Separation (1562)

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

Event Date 02/20/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 192-000j that has a similar product distributed in the us, list number 192-000.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.

Event Description

A customer reported while inserting the nasopharyngeal swab from the id now covid-19 2.0 test kit into a patient nose, the cotton swab head become lodged inside their nasal cavity on (b)(6) 2023.The customer reported that an otolaryngologist removed the cotton swab from the patient's nose.The customer did not report any additional details of patient harm, delay or impact in the patient's treatment.

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retain kit lot m217624 during routine complaint testing lots p0848/p0847/s0658 and pn pk002546/pk002546/pk002197.No damage or defects were observed on the patient swabs.All tests were valid and performed as expected.The current overall incident rate for breaks during use nasopharyngeal swabs for lot m217624 based on the total quantity of kits distributed is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.

Event Description

A customer reported while inserting the nasopharyngeal swab from the id now covid-19 2.0 test kit into a patient nose, the cotton swab head become lodged inside their nasal cavity on (b)(6) 2023.The customer reported that an otolaryngologist removed the cotton swab from the patient's nose.The customer did not report any additional details of patient harm, delay or impact in the patient's treatment.

• Brand Name: ID NOW COVID-19 2.0 TEST KIT 24T JAPAN
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• 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: 16440142
• MDR Text Key: 310334775
• Report Number: 1221359-2023-00395
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: JP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2023
• Device Catalogue Number: 192-000J
• Device Lot Number: M217624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2022
• 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