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

Catalog Number	190-000
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Single use: device discarded.
Event or Problem Description
The customer reported a conflicting result with the id now covid-19 assay performed on (b)(6) 2023 on a nasal swab.The first test generated a positive result while the second test generated a negative result.Repeat testing was performed on (b)(6) 2023 with the id now covid-19 assay on a nasal swab and generated a negative result.The customer stated the patient asymptomatic.The customer confirmed there was no harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.
Event or Problem Description
The customer reported a conflicting result with the id now covid-19 assay performed on (b)(6) 2023 on a nasal swab.The first test generated a positive result while the second test generated a negative result.Repeat testing was performed on (b)(6) 2023 with the id now covid-19 assay on a nasal swab and generated a negative result.The customer stated the patient was asymptomatic.The customer confirmed there was no harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.
Additional Manufacturer Narrative
Investigation report: testing was performed in duplicate at abbott diagnostics scarborough, inc.On retained kit lot 1086227 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 kit part number 190-000 / lot 1086227 and test base part number 190-430 / lot 1086227.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 1086227 showed that the complaint rate is (b)(4).A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 1086227 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.Substances in the sample itself may have interfered with the reaction.H3 other text: single use: device discarded.

• Brand Name: ID NOW COVID-19 TEST KIT 24T (EUA)
• Common Device Name: 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: 16198101
• Report Number: 1221359-2023-00120
• Device Sequence Number: 14904750
• Product Code: QJR
• UDI-Device Identifier: 10811877011269
• UDI-Public: 10811877011269
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EUA2000074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

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 Expiration Date: 05/11/2023
• Device Catalogue Number: 190-000
• Device Lot Number: 1086227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown