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

Catalog Number 193-000

Device Problem Non Reproducible Results (4029)

Patient Problem Insufficient Information (4580)

Event Date 01/31/2023

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 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 one conflicting result and one false positive result with the id now covid-19 2.0 assay for two patients performed on (b)(6) 2023.This mfr.Report addresses patient 1(one) of 2 (two).The customer reported conflicting results with the id now covid-19 2.0 assay for performed on (b)(6) 2023 directly tested on a nasal swab.Initial test was positive.Repeat testing (x2) was performed on the same day and generated a negative result and positive result respectively.The customer confirmed there was no patient harm due to the test results.However, stated that there was a delay in surgery due to the test results.

Manufacturer Narrative

Additional information: h4 this report is being filed on an international product, list number 193-000 that has a similar product distributed in the us, list number 192-000.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot m216420 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 193-000 / lot m216420, test base part number 193-430 / lot m216420.The lot met the required release specifications.A review of the complaints reported as false positive and false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot m216420 showed that the complaint rate is (b)(4)% and (b)(4)% respectively.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.Corrected: h10 - false negative complaint rate: (b)(4)% h3 other text : single-use, device discarded.

Event Description

The customer reported one conflicting result and one false positive result with the id now covid-19 2.0 assay for two patients performed on (b)(6) 2023.This mfr.Report addresses patient one (1) of two (2).The customer reported conflicting results with the id now covid-19 2.0 assay performed on (b)(6) 2023 directly tested on a nasal swab.Initial test was positive.Repeat testing (x2) was performed on the same day and generated a negative result and positive result respectively.The customer confirmed there was no patient harm due to the test results.However, stated that there was a delay in surgery due to the test results.

Manufacturer Narrative

This report is being filed on an international product, list number 193-000 that has a similar product distributed in the us, list number 192-000.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot m216420 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 193-000 / lot m216420, test base part number 193-430 / lot m216420.The lot met the required release specifications.A review of the complaints reported as false positive and false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot m216420 showed that the complaint rate is (b)(4)% and (b)(4)% respectively.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 one conflicting result and one false positive result with the id now covid-19 2.0 assay for two patients performed on (b)(6) 2023.This mfr.Report addresses patient one (1) of two (2).The customer reported conflicting results with the id now covid-19 2.0 assay performed on (b)(6) 2023 directly tested on a nasal swab.Initial test was positive.Repeat testing (x2) was performed on the same day and generated a negative result and positive result respectively.The customer confirmed there was no patient harm due to the test results.However, stated that there was a delay in surgery due to the test results.

• Brand Name: ID NOW COVID-19 2.0 TEST KIT 24T OUS
• 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: 16330037
• MDR Text Key: 309176741
• Report Number: 1221359-2023-00259
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2023
• Device Catalogue Number: 193-000
• Device Lot Number: M216420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2022
• 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