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	09/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight: 70.3 kilogram.The investigation is still in progress.A supplemental report will be provided after completion.
Event or Problem Description
The customer reported a false positive result with the id now covid-19 assay performed on (b)(6) 2022 using a direct tested anterior nasal swab sample.Retesting was performed on the same day with the id now covid-19 assay and generated a negative result.Confirmation pcr testing was performed on (b)(6) 2022 that generated a negative result on a nasopharyngeal sample.The patient was reportedly asymptomatic.
Additional Manufacturer Narrative
This report was filed in error as a duplicate.This incident was originally reported under mfr report number 1221359-2022-04779.Any updates, including investigation conclusion, will be submitted under mfr report number 1221359-2022-04779.

• 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: 15729549
• Report Number: 1221359-2022-05236
• Device Sequence Number: 14185760
• 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
• Report Date (Section B): 11/07/2022

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 Catalogue Number: 190-000
• Device Lot Number: 1081726
• 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: 10/14/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 11/07/2022
• 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: 80 YR
• Patient Sex: Male
• Patient Race: White