MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW COVID-19 ASSAY; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Catalog Number	190-000
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 1021947 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 190-000 / lot: 1021947, test base part number 190-430 / lot: 1021947.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 1021947 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue; however it could be related to the specific patient samples or cross contamination.Reference mfr.Report numbers 1221359-2021-00780, 1221359-2021-00781, 1221359-2021-00782, 1221359-2021-00772, 1221359-2021-00773, and 1221359-2021-01684.
Event or Problem Description
The customer reported false positive results with the id now covid-19 assay for multiple patients performed on various dates with two (2) different lot numbers.This mfr.Report six (6) of six (6).This report represents two (2) patients with lot number 1021947.Identifying patient demographics were not provided.The customer reported two (2) false positive result with the id now covid-19 assay performed on (b)(6) 2021 a direct tested nasal kitted swab.The nasal swab was used to swab both nostrils and repeat testing was performed.Confirmation testing on nasal swabs with pcr generated negative results; ct values not provided.The customer stated the patients were pre-surgical and were being tested before surgery.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 ASSAY
• 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
• MDR Report Key: 16074892
• Report Number: 1221359-2022-05322
• Device Sequence Number: 6334327
• Product Code: QJR
• UDI-Device Identifier: 10811877011269
• UDI-Public: 0110811877011269172108021010
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EUA2000074
• 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
• Report Date (Section B): 12/29/2022

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: 08/02/2021
• Device Catalogue Number: 190-000
• Device Lot Number: 1021947
• 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: 02/22/2021
• Initial Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2021
• 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