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

Catalog Number	195100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.A supplemental report will be provided after completion.
Event or Problem Description
The consumer reported sustaining a nasal injury while using the binaxnow covid-19 home test.The consumer reported an unspecified amount blood on the swab.(b)(6) reported that it was unclear if the consumer's nasal was swabbed twice.(b)(6) also, reported that it appeared the proctor stopped the session before any testing could take place so no actual testing occurred.However, an invalid result was reported.Although requested, no additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
The supplemental report is being submitted to provide additional information snd correct the pma/510k number from eua(b)(4) to eua(b)(4).Additional information: a product deficiency was not reported or identified.According to the package insert in195100 v.5.0: reagents and materials extraction reagent (1 or 2): bottle containing <1 ml of extraction reagent precautions invalid results can occur when an insufficient volume of extraction reagent is added to the test card.To ensure delivery of adequate volume, hold vial vertically, 1/2 inch above the swab well, and add drops slowly.Directions for running the binaxnow¿ covid-19 ag card home test 4.Apply fluid to top hole a.Remove dropper bottle cap.B.Hold dropper bottle straight over top hole, not at an angle.C.Put 6 drops into top hole.Do not touch card with tip.The product will continue to be monitored and tracked.
Additional Manufacturer Narrative
The supplemental report is being submitted to correct the previously reported event.Corrected data: b4- initial report date of this report should be 30-jul-2021.

• Brand Name: BINAXNOW COVID-19 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: erina marshall ; 10 southgate road; scarborough, ME 04074
• MDR Report Key: 12257077
• Report Number: 1221359-2021-02121
• Device Sequence Number: 17328996
• Product Code: QKP
• UDI-Device Identifier: 00811877011330
• UDI-Public: 01008118770113301721100310142400
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 11/28/2022

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: 195100
• Device Lot Number: 142400
• 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: 07/05/2021
• Supplement Date Received by Manufacturer: 04/11/2022; 11/28/2022
• Initial Report FDA Received Date: 07/31/2021
• Supplement Report FDA Received Date: 05/06/2022; 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female