MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY; CORONAVIRUS ANTIGEN DETECTION SYSTEM

Catalog Number 256082

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

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).(b)(6).

Event Description

It was reported while testing for sars cov-2 2 false negative results were obtained.Repeat tests were performed using pcr and the results were positive.There was no indication that results were reported out and there was no report of patient impact.Eua#: (b)(4).

Manufacturer Narrative

Investigation summary: this memo is to summarize the investigation results regarding your complaints that alleges false negative or discrepant results when using kit bd veritor for rapid detection of sars-cov-2 (mn# 256082), batch number unknown.Bd quality performs a systematic approach to investigate false negative complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples if applicable.The investigation could not be performed as no batch number was provided.The complaint was unable to be confirmed.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.

Event Description

It was reported while testing for sars cov-2 2 false negative results were obtained.Repeat tests were performed using pcr and the results were positive.There was no indication that results were reported out and there was no report of patient impact.Eua#: (b)(4).

• Brand Name: BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY
• Type of Device: CORONAVIRUS ANTIGEN DETECTION SYSTEM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 10823354
• MDR Text Key: 215922817
• Report Number: 1119779-2020-00980
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256082
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1