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	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.A supplemental report will be provided after completion.Reference mfr numbers : 1221359-2022-04774 through 1221359-2022-04780.
Event or Problem Description
The customer reported seven (7) conflicting results with the id now covid-19 assay for seven (7) patients performed on various dates.This report addresses patient two (2) of seven (7).The customer reported a conflicting result with the id now covid-19 assay performed on (b)(6) 2022 on a direct tested nasal swab.Repeat testing was performed and generated a negative result.As per customer patient was not symptomatic.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the investigation conclusion and additional information to the previously reported event.Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 1081726 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 1081726 and test base part number 190-430 / lot 1081726.The lot met the required release specifications.A review of the complaints reported as conflicting patient results (confirmed and unconfirmed, conflicting results) related to kit lot 1081726 showed that the complaint rate; for false positive patient result is (b)(4), and for false negative patient result is (b)(4).In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.However, a possible assignable root cause is patient sample interference.Substances in the sample itself may have interfered with the reaction.
Additional Manufacturer Narrative
Reference mfr: 1221359-2022-04774 to 1221359-2022-04780.
Event or Problem Description
The customer reported six (6) conflicting results and one (1) false positive result with the id now covid-19 assay for seven (7) patients on various dates.This report addresses patient one (2) of seven (7).

• 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 ; 6613888803
• MDR Report Key: 15528764
• Report Number: 1221359-2022-04775
• Device Sequence Number: 19459410
• Product Code: QJR
• UDI-Device Identifier: 10811877011269
• UDI-Public: 011081187701126917230401101081726
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 12/22/2022

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: 04/01/2023
• Device Catalogue Number: 190-000
• Device Lot Number: 1081726
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 10/14/2022; 12/05/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 11/07/2022; 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White