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 FROM CLINIC

Catalog Number	192-000
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported false negative results with the id now covid-19 2.0 assay for three (3) to five (5) patients, performed on (b)(6) 2025 and (b)(6) 2025.The customer indicated that the patients were ¿older¿.This mfr.Report addresses patient one (1) of five (5).Initial testing was performed with health rapid self-test covid-19 flu a&b 3-in-1 tests and produced positive results.Confirmation testing with the id now covid-19 2.0 assay was performed the same day as the rapid self-test with nasal swabs and generated negative results.The customer stated the patients were symptomatic at the time of testing and that no repeat or additional testing was performed.The customer indicated that that the patients were not prescribed paxlovid and that their symptoms worsened (fever, body aches, chills, cough, sore throat, headaches, runny nose, nasal congestion).The customer did not report if any treatment or medical intervention was required.The current health status of the patient was not reported.No additional information was obtained.
Additional Manufacturer Narrative
B3: the date indicated is an approximation as the exact event date was not provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Correction: d2a - common device name: simple point-of-care device to detect sar-cov-2 nucleic acid targets from clinical specimens in near-patient setting.B3: the date indicated is an approximation as the exact event date was not provided.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 000m925680 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 192-000/lot 000m925680 and test base part number 192-430/ lot 000m925680.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 000m925680 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 can be sample interference.
Event or Problem Description
The customer reported false negative results with the id now covid-19 2.0 assay for three (3) to five (5) patients, performed on (b)(6) 2025.The customer indicated that the patients were ¿older¿.This mfr.Report addresses patient one (1) of five (5).Initial testing was performed with health rapid self-test covid-19 flu a&b 3-in-1 tests and produced positive results.Confirmation testing with the id now covid-19 2.0 assay was performed the same day as the rapid self-test with nasal swabs and generated negative results.The customer stated the patients were symptomatic at the time of testing and that no repeat or additional testing was performed.The customer indicated that that the patients were not prescribed paxlovid and that their symptoms worsened (fever, body aches, chills, cough, sore throat, headaches, runny nose, nasal congestion).The customer did not report if any treatment or medical intervention was required.The current health status of the patient was not reported.No additional information was obtained.

• 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 FROM CLINIC
• 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: 23039043
• Report Number: 1221359-2025-00359
• Device Sequence Number: 10054505
• Product Code: QWR
• UDI-Device Identifier: 00811877011354
• UDI-Public: (01)00811877011354(17)260902(10)000M925680
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2026
• Device Catalogue Number: 192-000
• Device Lot Number: 000M925680
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown