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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported false positive results with the id now covid-19 2.0 assay performed on (b)(6) 2024 on a nasal sample using the kit swab.This manufacturer¿s report addresses test one (1) of two (2) for patient one (1) of three (3).The customer performed an additional test on the same day on a different id now instrument and generated a negative result.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient¿s treatment.
Additional Manufacturer Narrative
D2a - common device name: simple point-of-care device to detect sar-cov-2 nucleic acid targets from clinical specimens in near-patient settings the remainder of the investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.
Additional Manufacturer Narrative
D2a - common device name: simple point-of-care device to detect sar-cov-2 nucleic acid targets from clinical specimens in near-patient settings testing was performed at abbott diagnostics scarborough, inc.On retained kit lot m820561 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 m820561 and test base part number 192-430/lot m820561.The lot met the required release specifications.A review of the complaints reported false positive patient results (confirmed and unconfirmed, conflicting results) related to kit lot m820561 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 could be patient sample interference.
Event or Problem Description
The customer reported false positive results with the id now covid-19 2.0 assay performed on (b)(6) 2024 on a nasal sample using the kit swab.This manufacturer¿s report addresses test one (1) of two (2) for patient one (1) of three (3).The customer performed an additional test on the same day on a different id now instrument and generated a negative result.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient¿s treatment.

• 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: 19636864
• Report Number: 1221359-2024-00431
• Device Sequence Number: 7400779
• Product Code: QWR
• UDI-Device Identifier: 00811877011354
• UDI-Public: (01)00811877011354(17)251105(10)M820561
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/08/2024

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: 11/05/2025
• Device Catalogue Number: 192-000
• Device Lot Number: M820561
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2023
• 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