MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW COVID-19 2.0 TEST KIT 24T (EUA); SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS

Catalog Number	192-000
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 (date of event): the date listed is an estimated date, as the consumer did not provide the actual date of the event.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported three (3) false negative results with the id now covid-19 assay performed on an unknown date using direct tested throat and nasopharyngeal samples.This is report one (1) of three (3).The patient initially tested negative with the id now covid-19 assay.Repeat testing was performed on two (2) different id now instruments, which generated negative results.Confirmation pcr testing was performed on (b)(6) 2025 with a nasal swab sample that generated a positive result.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
B3 (date of event): the date listed is an estimated date, as the consumer did not provide the actual date of the event.Corrections: a3b - gender.D1 - brand name.D2a - common device name, full name: simple point-of-care device to detect sar-cov-2 nucleic acid targets from clinical specimens in near-patient settings.D2b - procode corrected to align with d1.D4 - lot number added, catalog number corrected, expiration date added, serial number made na.D8 - made na.G4 - 510k number added.H4 - manufacture date added h6 - health impact code updated.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 000m983346 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 192-000 / lot: 000m983346, test base part number 192-430 / lot: 000m983346.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 000m983346 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.
Event or Problem Description
The customer reported three (3) false negative results with the id now covid-19 assay performed on an unknown date using direct tested throat and nasopharyngeal samples.This is report one (1) of three (3).The patient initially tested negative with the id now covid-19 assay.Repeat testing was performed on two (2) different id now instruments, which generated negative results.Confirmation pcr testing was performed on (b)(6) 2025 with a nasal swab sample that generated a positive result.No additional patient information, including treatment and outcome, was provided.

• Brand Name: ID NOW COVID-19 2.0 TEST KIT 24T (EUA)
• Common Device Name: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS
• 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: 23073822
• Report Number: 1221359-2025-00368
• Device Sequence Number: 11958589
• Product Code: QWR
• UDI-Device Identifier: 00811877011354
• UDI-Public: (01)00811877011354(17)270122(10)000M983346
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K221925
• 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): 11/04/2025

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 Catalogue Number: 192-000
• Device Lot Number: 000M983346
• 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: 09/05/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2025
• 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 Age: 50 YR
• Patient Sex: Male