MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW COVID-19 TEST KIT 24T (OUS); REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Catalog Number	191-000
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date is an approximation as the exact date was not reported.This report is being filed on an international product, list number: 193-000 that has a similar product distributed in the us, list number: 192-000.The investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.
Event or Problem Description
The customer reported an unknown number of false negative results with the id now covid-19 assay test performed on an unknown date.Confirmation pcr testing (unknown platform) was performed and generated positive results.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
B3: event date is an approximation as the exact date was not reported.This report is being filed on an international product, list number 193-000 that has a similar product distributed in the us, list number 192-000.The required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints' trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.H3 other text : single use ¿ device discarded.
Event or Problem Description
The customer reported an unknown number of false negative results with the id now covid-19 assay test performed on an unknown date.Confirmation pcr testing (unknown platform) was performed and generated positive results.No additional patient information, including treatment and outcome, was provided.

• Brand Name: ID NOW COVID-19 TEST KIT 24T (OUS)
• 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: 16597761
• Report Number: 1221359-2023-00539
• Device Sequence Number: 5310648
• Product Code: QJR
• UDI-Device Identifier: 00811877010593
• UDI-Public: 00811877010593
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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 Catalogue Number: 191-000
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 05/03/2023
• 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