MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW COVID-19 TEST KIT 24T (EUA); 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	09/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.A supplemental report will be provided after completion.Device discarded, single use device.
Event or Problem Description
The customer reported a false positive result with the id now covid-19 assay performed on (b)(6) 2022 on a nasal sample.Confirmation testing on nasopharyngeal sample with (platform: abbott m2000) generated a negative result (ct values not provided).No additional patient information, including treatment and outcome, was provided.
Event or Problem Description
The customer reported a false positive result with the id now covid-19 assay performed on 21sep2022 on a nasal sample.Confirmation testing on nasopharyngeal sample with (platform: abbott m2000) generated a negative result (ct values not provided).No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 1086021 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 108602, test base part number 190-430 / lot 1086021.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 1086021 showed that the complaint rate is 0.00192%.Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.However, a possible assignable root cause is sample interference or cross contamination.H3 other text: device discarded, single use device.

• Brand Name: ID NOW COVID-19 TEST KIT 24T (EUA)
• 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: 15663642
• Report Number: 1221359-2022-10023
• Device Sequence Number: 20450679
• Product Code: QJR
• UDI-Device Identifier: 10811877011269
• UDI-Public: 10811877011269
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 02/01/2023

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 Expiration Date: 05/09/2023
• Device Catalogue Number: 190-000
• Device Lot Number: 1086021
• 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: 09/30/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 02/01/2023
• 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