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

Catalog Number 256082

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2020

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).

Event Description

It was reported while testing for sars cov-2 2 false positive results were obtained.Repeat tests were performed using pcr and the results were negative.The customer stated they are testing asymptomatic patients.This test is not intended for use on asymptomatic patients and was therefore used off label.The customer stated there was no patient impact.(b)(4).

Event Description

It was reported while testing for sars cov-2 2 false positive results were obtained.Repeat tests were performed using pcr and the results were negative.The customer stated they are testing asymptomatic patients.This test is not intended for use on asymptomatic patients and was therefore used off label.The customer stated there was no patient impact.Eua#: eua (b)(4).

Manufacturer Narrative

H6: investigation summary: this statement is to summarize the investigation results regarding the complaints that alleges false positive results when using kit rapid detection of sars-cov-2 veritor (material # 256082), batch number unknown.Bd quality performs a systematic approach to investigate false positive complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation could not be performed as no batch number was provided.Samples were returned to bd as noted in tracking number 772561211029.Bd quality was not able to locate the returned samples.The investigation will be reopened if samples are located.The complaint was unable to be confirmed.A trend was identified for false positive results.A corrective and preventive action (capa) 1878253 has been opened to further investigate.The root cause could not be identified.Bd quality will continue to closely monitor for trends.There were no corrective actions taken at this time.

• Brand Name: BD RAPID DETECTION OF SARS-COV-2 VERITOR
• Type of Device: CORONAVIRUS ANTIGEN DETECTION SYSTEM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11248334
• MDR Text Key: 231400393
• Report Number: 1119779-2021-00175
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1