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 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: jb202306 was reported, however, this is not a lot# manufactured for this product #.Medical device expiration date: unknown.Fda notified?: the initial reporter also notified the fda on 2020-12-04 via medwatch #mw509815.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported while testing for sars cov-2 a false positive result was obtained.A repeat test was performed using a pcr test method and the result was negative.The customer stated the patient tested was asymptomatic.This test is not intended for use on asymptomatic patients and was therefore used off label.The results were reported out to the fda on medwatch# 509815.The patient was quarantined in the facilities' covid-19 unit.(b)(4).

Manufacturer Narrative

H.6.Investigation: this memo is to summarize the investigation results regarding the complaint 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, or an incorrect batch number was provided.The complaint was unable to be confirmed.Quality will continue to closely monitor for trends.

Event Description

It was reported while testing for sars cov-2 a false positive result was obtained.A repeat test was performed using a pcr test method and the result was negative.The customer stated the patient tested was asymptomatic.This test is not intended for use on asymptomatic patients and was therefore used off label.The results were reported out to the fda on medwatch# 509815.The patient was quarantined in the facilities' covid-19 unit.Eua (b)(4).

• 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: 11095514
• MDR Text Key: 225806996
• Report Number: 1119779-2020-01289
• 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: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256082
• Device Lot Number: JB202306
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1