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

Catalog Number 192-000

Device Problem Unable to Obtain Readings (1516)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

The customer reported an unknown number of invalid results with the id now covid-19 2.0 performed on an unknown date.Repeat testing was performed on an unknown date generating invalid results.Confirmation testing was not performed.The customer reported the patient experienced a delay in surgery due to the test results.Although requested, no additional patient information including the type of surgery that was delayed, treatment and outcome, was provided.

Manufacturer Narrative

The event date provided is an estimate as the exact date of occurrence was not provided.The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Single use, device discarded.

Manufacturer Narrative

The date provided in b3 is an estimate as the exact date of occurrence was not provided.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 1092567 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 number 192-000/ lot: 1092567, test base part number 192-430/ lot: 1092567.The lot met the required release specifications.A review of the complaints reported as invalid patient results (confirmed and unconfirmed, conflicting results) related to kit lot 1092567 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue; however, a possible assignable root cause is patient sample interference.H3 other text : single use, device discarded.

Event Description

The customer reported an unknown number of invalid results with the id now covid-19 2.0 performed on an unknown date.Repeat testing was performed on an unknown date generating invalid results.Confirmation testing was not performed.The customer reported the patient experienced a delay in surgery due to the test results.Although requested, no additional patient information including the type of surgery that was delayed, treatment and outcome, was provided.

• Brand Name: ID NOW COVID-19 2.0 TEST KIT 24T (EUA)
• 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: 16437439
• MDR Text Key: 310259225
• Report Number: 1221359-2023-00392
• Device Sequence Number: 1
• Product Code: QJR
• UDI-Device Identifier: 00811877011354
• UDI-Public: 00811877011354
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210517
• 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: 05/16/2023

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: 10/29/2023
• Device Catalogue Number: 192-000
• Device Lot Number: 1092567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2022
• 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