MAUDE Adverse Event Report: BD BD VERITOR PLUS ANALYZER SARS COV2 LATERAL FLOW ASSAY ANTIGEN POINT OF CARE; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 0213905

Device Problem False Positive Result (1227)

Patient Problem Test Result (2695)

Event Date 10/02/2020

Event Type  malfunction  

Event Description

Apparent false positive result for covid.Using the bd veritor plus analyzer sars cov2 antigen assay, a positive result was obtained in an asymptomatic exposed healthcare worker at an rcfe.A pcr assay from a simultaneously obtained np swab was negative by assay at our regional public health lab.(b)(6).Fda safety report id# (b)(4).

• Brand Name: BD VERITOR PLUS ANALYZER SARS COV2 LATERAL FLOW ASSAY ANTIGEN POINT OF CARE
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): BD
• MDR Report Key: 10704073
• MDR Text Key: 212304283
• Report Number: MW5097322
• Device Sequence Number: 1
• Product Code: QKP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0213905
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR