MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VERITOR SYSTEM FOR RAPID DETECTOR OF COVID SARS2; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2020

Event Type  Injury  

Event Description

Reporter stated that a covid test was done on one of their patient using the bd ventor system for rapid detector of covid-sars-2 on the afternoon of (b)(6) 2020 and the result came back positive.In the morning of that same day, a pcr (polymerase chain reaction) test was also done on the same patient and the result was negative.Reporter is reporting this to meet reporting regulation.

• Brand Name: BD VERITOR SYSTEM FOR RAPID DETECTOR OF COVID SARS2
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): BECTON, DICKINSON & CO.
• MDR Report Key: 10442929
• MDR Text Key: 204203432
• Report Number: MW5096210
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/21/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 75