MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAX NOW COVID-19 AG CARD HOME TEST 6CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number	195-100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: the events date is an estimation.The investigation is still in progress.A supplemental report will be provided after completion.H3 : device discarded, single use.
Event or Problem Description
The consumer reported two false negative results with binax now covid-19 ag on (b)(6) 2023.The consumer received negative results with binax now covid-19 ag in february, and a positive result at the doctor office.Per the consumer, she was symptomatic.This mfr.Report addresses test two (2) of two (2) tests.No additional patient information, including treatment and outcome, was provided.
Event or Problem Description
The consumer reported two false negative results with binax now covid-19 ag on unknown dates.The consumer received negative results with binax now covid-19 ag in february, and a positive result at the doctor office.Per the consumer, she was symptomatic.This mfr.Report addresses test two (2) of two (2) tests.No additional patient information, including treatment and outcome, was provided.
Additional Manufacturer Narrative
Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 177523 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 195-100/ lot 177523 and device part number 195-430h/ lot 172525.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot.177523 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue; however, it could possibly be related to issues including the self-test user performance, interpretation of the result, or the specific patient sample.D4: expiration date d4: udi number.
Additional Manufacturer Narrative
Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 177523 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 195-100/ lot 177523 and device part number 195-430h/ lot 172525.The lot met the required release specifications.A review of the complaints reported as false negative patient results (confirmed and unconfirmed, conflicting results) related to kit lot.177523 showed that the complaint rate is (b)(4).Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue; however, it could possibly be related to issues including the self-test user performance, interpretation of the result, or the specific patient sample.D1 - brand name.D4- lot number.D4 - catalog number.H6- impact code h3 other text : device discarded, single use.
Event or Problem Description
The consumer reported two false negative results with binax now covid-19 ag on (b)(6)2023.The consumer received negative results with binax now covid-19 ag in february, and a positive result at the doctor office.Per the consumer, she was symptomatic.This mfr.Report addresses test two (2) of two (2) tests.No additional patient information, including treatment and outcome, was provided.

• Brand Name: BINAX NOW COVID-19 AG CARD HOME TEST 6CT
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• 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: 17083571
• Report Number: 1221359-2023-01198
• Device Sequence Number: 6273467
• Product Code: QKP
• UDI-Device Identifier: 00811877011330
• UDI-Public: 00811877011330
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2023

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: 09/21/2023
• Device Catalogue Number: 195-100
• Device Lot Number: 177523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 06/14/2023; 06/21/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 06/20/2023; 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White