MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC ID NOW COVID-19; MOLECULAR IVD FOR ID NOW COVID-19

Catalog Number	191-000
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: testing was performed at abbott diagnostics (b)(4), inc.On retained kit lot m167101 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 191-000 / lot m167101 and test base part number 190-430 / lot m167101.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 m167101 showed that the complaint rate is (b)(4).Abbott diagnostics (b)(4) was unable to determine the exact root cause of the reported issue however a possible assignable root cause is patient sample interference.
Event or Problem Description
The customer reported a false positive result with the id now covid-19 assay performed on (b)(6) 2021.The customer performed three id now covid-19 assay on the patient on (b)(6) 2021, the first two yielded an invalid and the third a positive result.No additional patient information, including treatment and outcome, was provided.

• Brand Name: ID NOW COVID-19
• Common Device Name: MOLECULAR IVD FOR ID NOW COVID-19
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: kindra sudduth ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 13142172
• Report Number: 1221359-2021-04010
• Device Sequence Number: 20000214
• Product Code: QJR
• UDI-Device Identifier: 00811877010593
• UDI-Public: 0100811877010593
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/31/2021

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: Lay User/Patient
• Device Expiration Date: 07/20/2022
• Device Catalogue Number: 191-000
• Device Lot Number: M167101
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 01/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2021
• 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 Age: 70 YR
• Patient Sex: Unknown
• Patient Weight: 50 KG