MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Catalog Number 195-160

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2022

Event Type  malfunction  

Manufacturer Narrative

The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Device discarded, single use device.

Event Description

The consumer reported two (2) false negative results with the binaxnow covid-19 ag self-test for performed by her on (b)(6) 2022 and on (b)(6) 2022.This mfr.Report addresses test one (1) of two (2).The customer reported a false negative result with the binaxnow covid-19 ag self-test performed on (b)(6) 2022 on a nasal/throat kitted swab.Pcr confirmation testing was performed (platform: kaiser, sample type unknown) generated negative (ct values not provided) the consumer stated that she was symptomatic and experiencing cough, sleepy and sickness symptoms.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.

Manufacturer Narrative

The required intake information to enable further investigation, such as the kit's lot number, was not provided and an lot-specific investigation was not able to be performed.Notwithstanding, a review of complaints' trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.H3 other text : device discarded, single use device.

Event Description

The consumer reported two (2) false negative results with the binaxnow covid-19 ag self-test for performed by her on (b)(6) 2022 and (b)(6) 2022.This mfr.Report addresses test one (1) of two (2).The customer reported a false negative result with the binaxnow covid-19 ag self-test performed on (b)(6) 2022 on a nasal/throat kitted swab.Pcr confirmation testing was performed (platform: (b)(6), sample type unknown) generated negative (ct values not provided) the consumer stated that she was symptomatic and experiencing cough, sleepy and sickness symptoms.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.

• Brand Name: BINAXNOW COVID-19 AG SELF TEST 2CT
• Type of Device: 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: 15670733
• MDR Text Key: 302480805
• Report Number: 1221359-2022-10027
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: 00811877011408
• Combination Product (y/n): N
• PMA/PMN Number: EUA210264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 195-160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 01/03/2023
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female