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 Incorrect Measurement (1383)

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

Event Date 10/20/2022

Event Type  malfunction  

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Device discarded, single use device.

Event Description

The customer reported qc test failing with id now covid-19 2.0 test kit on (b)(6) 2022.Per customer, there was a delay in patient's surgery due to qc failing test.No additional patient information, including treatment and outcome, was provided.

Event Description

The customer reported qc test failing with id now covid-19 2.0 test kit on (b)(6) 2022.Per customer, there was a delay in patient's surgery due to qc failing test.No additional patient information, including treatment and outcome, was provided.

Manufacturer Narrative

The customer reported that they received multiple qc test failures for the id now covid-19 kit lot 1090687 on id now instrument (b)(4).Upon further investigation, it was discovered that the qc testing was performed using an id now covid-19 1.0 test kit swab instead of the id now covid-19 2.0 test kit swabs on (b)(6) 2022.The customer re-ran the qc utilizing the correct testing swabs and receiving passing results for the qc testing.Testing of updated instrument using previous version test kits is considered off-label and is not supported for use by abbott rapid diagnostics scarborough.No further actions required.Based on the above summary, the investigation is deemed complete.Abbott diagnostics scarborough will continue to monitor and trend for this reported issue.H3 other text : device discarded, single use device.

• 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: 15753613
• MDR Text Key: 305187196
• Report Number: 1221359-2022-10075
• 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: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 192-000
• Device Lot Number: 1090687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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