MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH INC. BINAX NOW COVID-19 AG CARD; LATERAL FLOW IMMUNOASSAY IVD OF COVID-19

Catalog Number 195-000

Device Problem False Negative Result (1225)

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

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be submitted after completion.Please see related mfr report # (b)(4).

Event Description

A customer sent a cumulative report of two false negative results with the id now covid-19 assay.This report represents patient two of two.The customer reported a false negative result from a kitted nasal swab of both nostrils with the binax now covid-19 ag card assay performed on (b)(6) 2020.The customer indicated that confirmation testing with pcr was conducted ((b)(6) 2020) and generated positive results.The customer reported that the patient was asymptomatic.The customer also reported that the patient was not on any treatment and self-quarantining.The customer confirmed there was no death or serious injury and treatment was not impacted/delayed.Per binax now covid-19 ag card product insert intended use: negative results from patients with symptom onset beyond seven days should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed.Negative results do not rule out sars-cov-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.Negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with covid-19.Per binax now covid-19 ag card product insert precautions and limitations: inadequate or inappropriate sample collection, storage, and transport may yield false test results.False negative results can occur if the sample swab is not rotated (twirled) prior to closing the card.False results may occur if specimens are tested past 1 hour of collection.Specimens should be tested as quickly as possible after specimen collection.False negative results may occur if inadequate extraction buffer is used (e.G.,<6 drops).False negative results may occur if swabs are stored in their paper sheath after specimen collection.The presence of mupirocin may interfere with the binaxnow covid-19 ag test and may cause false negative results.Due to the risk of false negative results potentially leading to no or delayed treatment, this event shall be reported.

Manufacturer Narrative

Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 130445 with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing batch records and quality control release testing for kit part number 195-000 / lot 130445 and device part number 195-430h / lot 129163 were reviewed.This 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 130445 showed that the complaint rate is 0.001%.Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue; however, it could possibly be related to the specific patient samples.The available evidence suggests that this device lot is performing within the statements made within package insert related to % test agreement with the expected results by sample concentration.Please see related mfr report # 1221359-2020-00443.

• Brand Name: BINAX NOW COVID-19 AG CARD
• Type of Device: LATERAL FLOW IMMUNOASSAY IVD OF COVID-19
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: alexa wakley ; 10 southgate road; scarborough, ME 04074 ; 2077305750
• MDR Report Key: 11103166
• MDR Text Key: 239393671
• Report Number: 1221359-2020-00444
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 10811877011290
• UDI-Public: 01108118770112901721040910128694130445
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA202537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

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: Health Professional
• Device Expiration Date: 04/21/2021
• Device Catalogue Number: 195-000
• Device Lot Number: 130445
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 01/12/2021
• Supplement Dates FDA Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 73