MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG CARD HOME TEST; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number	195-100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date: this event is being reported out of an abundance of caution due to the probability that the patient had used the nasal swab which had been dipped into reagent in the test card.The investigation is still in progress.A supplemental report will be provided after completion.
Event or Problem Description
The customer reported that the patient was taking the binaxnow covid-19 home test at a hotel and during the interpretation of the results, the patient indicated that they had inserted the nasal swab into the top hole of the test card and then inserted the swab into their nostril to obtain sample.It is currently unknown if the patient had initially placed the reagent of the binaxnow covid-19 home test in the top hole of the test card as per procedure.No further information regarding patient health status or outcome was provided.
Additional Manufacturer Narrative
Investigation report: the customer reported the test taker dipped the swab in the top hole of the test card before swabbing their nostrils when they performed the binaxnow covid-19 antigen home test.The customer reported as a result of this, the results were submitted as invalid.The customer confirmed that no additional information is available.Emed support confirmed that the test taker will receive a replacement test kit.Technical services provided the reagent safety data sheet to the test taker.The product will continue to be monitored and tracked.

• Brand Name: BINAXNOW COVID-19 AG CARD HOME TEST
• Common Device Name: LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
• 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: 14999576
• Report Number: 1221359-2022-03440
• Device Sequence Number: 1563117
• Product Code: QKP
• UDI-Device Identifier: 00811877011330
• UDI-Public: 01008118770113301723040610187030
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EUA203107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 195-100
• Device Lot Number: 187030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 07/24/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown