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	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a conflicting result with the id now covid-19 2.0 assay performed on (b)(6) 2024.This report is for patient one (1) of two (2).The customer tested the same patient sample in the same sample receiver in two separate instruments on the same day.The first instrument returned a negative result, and the second instrument returned a positive result.The patient was reported to have been covid-19 positive 9 days prior to testing.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
D2a: simple point-of-care device to detect sar-cov-2 nucleic acid targets from clinical specimens in near-patient settings the results of the investigation are still pending.A supplemental report will be submitted upon completion or upon receipt of additional information.
Additional Manufacturer Narrative
B5: correction - the customer reported conflicting results with the id now covid-19 2.0 assay for two patients performed on multiple dates.This manufacturer report addresses patient one (1) of two (2).The customer reported conflicting results with the id now covid-19 2.0 assay performed on (b)(6) 2024.The customer tested the same patient sample in two separate instruments on the same day.The first test returned a negative result, and the second test returned a positive result.The patient was reported to have been covid-19 positive 9 days prior to testing.No additional patient information, including treatment and outcome, was provided.D2a: simple point-of-care device to detect sar-cov-2 nucleic acid targets from clinical specimens in near-patient settings d9: correction - na.H6: correction - f24.The results of the investigation are still pending.A supplemental report will be submitted upon completion or upon receipt of additional information.
Event or Problem Description
The customer reported conflicting results with the id now covid-19 2.0 assay for two patients performed on multiple dates.This manufacturer report addresses patient one (1) of two (2).The customer reported conflicting results with the id now covid-19 2.0 assay performed on (b)(6) 2024.The customer tested the same patient sample in two separate instruments on the same day.The first test returned a negative result, and the second test returned a positive result.The patient was reported to have been covid-19 positive 9 days prior to testing.No additional patient information, including treatment and outcome, was provided.
Event or Problem Description
The customer reported conflicting results with the id now covid-19 2.0 assay for two patients performed on multiple dates.This manufacturer report addresses patient one (1) of two (2).The customer reported conflicting results with the id now covid-19 2.0 assay performed on (b)(6) 2024.The customer tested the same patient sample in two separate instruments on the same day.The first test returned a negative result, and the second test returned a positive result.The patient was reported to have been covid-19 positive 9 days prior to testing.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
D2a: simple point-of-care device to detect sar-cov-2 nucleic acid targets from clinical specimens in near-patient settings the manufacturing records and quality control release testing was reviewed for test kit part number 192-000 / lot 1100449 and est base part number 192-430 / lot 1100449.The lot met the required release specifications.A review of the complaints reported as false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot 1100449 showed that the complaint rate is (b)(4).A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot 1100449 showed that the complaint rate is (b)(4).Retained testing was unable to be performed due to the lot being expired.Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue, however it could have possibly been related to sample interference.

• 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: 20232462
• Report Number: 1221359-2024-00607
• Device Sequence Number: 18370967
• Product Code: QWR
• UDI-Device Identifier: 00811877011354
• UDI-Public: (01)00811877011354(17)240102(10)1100449
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 03/20/2025

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 Expiration Date: 10/02/2024
• Device Catalogue Number: 192-000
• Device Lot Number: 1100449
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 09/19/2024; 03/18/2025
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 09/23/2024; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2022
• 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