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 Non Reproducible Results (4029)

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

Event Date 02/06/2023

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 conflicting results with the id now covid-19 2.0 assay performed on (b)(6) 2023.The patient initially tested positive with the id now covid-19 2.0 assay.The customer performed a repeat test with another id now covid-19 2.0 assay which generated a negative result.The patient was asymptomatic.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

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.Additional information from the customer indicated that the first test was conducted with lot m216837, and the second test was conducted with one (1) of two (2) lot numbers: lot: m216837, exp.Date: 08oct2023, device mfg date: 10sep2022.Lot: m216865, exp.Date: 08oct2023, device mfg date: 10sep2022.See updates to: d4 - lot number, d4 - exp date, h4 - device mfg.Date.The investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.H3 other text : single use; device discarded.

Event Description

The customer reported conflicting results with the id now covid-19 2.0 assay performed on (b)(6) 2023.The patient initially tested positive with the id now covid-19 2.0 assay.The customer performed a repeat test with another id now covid-19 2.0 assay which generated a negative result.The patient was asymptomatic.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.

Event Description

The customer reported conflicting results with the id now covid-19 2.0 assay performed on (b)(6) 2023.The patient initially tested positive with the id now covid-19 2.0 assay.The customer performed a repeat test with another id now covid-19 2.0 assay which generated a negative result.The patient was asymptomatic.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

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.Additional information from the customer indicated that the first test was conducted with lot m216837, and the second test was conducted with one (1) of two (2) lot numbers: lot: m216837, exp.Date: (b)(6) 2023, device mfg date: 10sep2022 lot: m216865, exp.Date: (b)(6) 2023, device mfg date: 10sep2022 investigation conclusion: testing was performed at abbott diagnostics scarborough, inc.On retained kit lots m216837 and m216865 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 192-000j / lot m216837 and lot m216865, test base part number 192-430 / lot m216837 and lot m216865.The lots 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 m216837 showed that the complaint rate is (b)(4)% and (b)(4)%, respectively.A review of the complaints reported as false positive and false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot m216865 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.

• 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: 16380948
• MDR Text Key: 309603234
• Report Number: 1221359-2023-00321
• 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,Followup
• Report Date: 05/02/2023

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: 10/08/2023
• Device Catalogue Number: 192-000J
• Device Lot Number: M216837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 03/19/2023; 04/26/2023
• Supplement Dates FDA Received: 03/29/2023; 05/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2022
• 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