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 Problems Break (1069); Material Separation (1562)

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

Event Date 02/14/2023

Event Type  malfunction  

Event Description

The customer reported that during use of the id now covid-19 2.0 assay on a child, the head of the nasal pharyngeal swab dislodged and was left in the nasal pharyngeal cavity of the patient.The doctor removed the swab head with tweezers.The customer confirmed there was no harm to the patient.

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 investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.Single use; device discarded.

Event Description

The customer reported that during use of the id now covid-19 2.0 assay on a child, the head of the nasal pharyngeal swab dislodged and was left in the nasal pharyngeal cavity of the patient.The doctor removed the swab head with tweezers.The customer confirmed there was no harm to the patient.

Manufacturer Narrative

D4, g4: 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.Investigation conclusion: inspections were performed at abbott diagnostics scarborough, inc.During routine complaint testing on retained kit lot m217624.No damage or defects were observed on the patient swab lots p0848/p0847/s0658 and part number pk002546/pk002546/pk002197.The customer's complaint was not replicated.Additionally, the manufacturing records and quality control release documentation were reviewed for kit blank swab part number pk002546, pk002546, pk002197 / kit swab lot number p0848, p0847, s0658; the accessory met all release criteria.A review of the complaints reported as broken swab during nasopharyngeal use for lot m217624 based on the total quantity of kits distributed is 0.00543%.The reported issue is anticipated in nature and severity for id now covid-19 according to risk documentation.Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.H6 - medical device problem code h3 other text : single use; device discarded.

• 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: 16432650
• MDR Text Key: 310259107
• Report Number: 1221359-2023-00390
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 05/09/2023
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: No
• 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