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 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.A supplemental report will be submitted after completion.

Event Description

The customer reported a false negative result with the binax now covid-19 ag card assay performed on (b)(6) 2020.No additional information related to sample collection was provided.The customer indicated that confirmation testing with pcr was conducted (date of test and ct values were not provided) and results were not specified.Although requested, no additional information including patient information, treatment, impact or outcome was provided by the customer.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

Additional information: the customer did not provide the required intake information, such as the kit's lot, and an 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 (b)(4) was unable to determine the exact root cause of the reported issues as no information was provided for investigation.

• 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: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 11068260
• MDR Text Key: 241472132
• Report Number: 1221359-2020-00464
• Device Sequence Number: 1
• Product Code: QKP
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

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: No Information
• Device Catalogue Number: 195-000
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 02/11/2021
• Supplement Dates FDA Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1