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	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Device discarded, single use device.
Event or Problem Description
The customer reported a false negative result with the idnow covid-19 assay performed (unknown) on a nasal swab sample collected on (b)(6) 2022.Confirmation testing (platform: diasorin) on a nasopharyngeal sample collected on (b)(6) 2022 in viral transport media generated a positive result.Per the customer, no additional information will be provided.
Additional Manufacturer Narrative
Testing was performed in duplicate at abbott diagnostics scarborough, inc.On retained kit lot 1086836 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 1086836 and test base part number 190-430 / lot 1086836.Quality control release testing met specifications and there were no false negative results observed.The review of the complaints reported as false negative results (confirmed, unconfirmed and conflicting results) related to kit lot 1086836 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough 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 : device discarded, single use device.
Event or Problem Description
The customer reported a false negative result with the idnow covid-19 assay performed (unknown) on a nasal swab sample collected on (b)(6)2022.Confirmation testing (platform: diasorin) on a nasopharyngeal sample collected on (b)(6)2022 in viral transport media generated a positive result.Per the customer, no additional information will be provided.

• 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: 15842748
• Report Number: 1221359-2022-10175
• Device Sequence Number: 12514689
• Product Code: QJR
• UDI-Device Identifier: 10811877011269
• UDI-Public: 10811877011269
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/27/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2023
• Device Catalogue Number: 190-000
• Device Lot Number: 1086836
• 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: 11/09/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 01/27/2023
• 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