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 Virus (2136); Vomiting (2144); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported while testing for sars-cov-2 a false negative result was obtained.The patient was experiencing vomiting, a sample was collected, and the result was negative.The patients condition worsened and they were transferred to a hospital.The patient tested positive for covid via pcr a few days after admission.There was no further information provided from the customer.(b)(4).

Event Description

It was reported while testing for sars-cov-2 a false negative result was obtained.The patient was experiencing vomiting, a sample was collected, and the result was negative.The patients condition worsened and they were transferred to a hospital.The patient tested positive for covid via pcr a few days after admission.There was no further information provided from the customer.(b)(4).

Manufacturer Narrative

The following information has been updated: h.6.Fda patient problem code(s): 1930.

Event Description

It was reported while testing for sars-cov-2 a false negative result was obtained.The patient was experiencing vomiting, a sample was collected, and the result was negative.The patients condition worsened and they were transferred to a hospital.The patient tested positive for covid via pcr a few days after admission.There was no further information provided from the customer.(b)(4).

Manufacturer Narrative

H6: investigation summary: this statement is to summarize the investigation results regarding the complaint that alleges false negative or discrepant results when using kit bd veritor for rapid detection of sars-cov-2 (mn# (b)(4)), batch number 0198093 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.An investigation and testing were performed on the batch number 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.H3 other text : see h10.

• 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: 10759227
• MDR Text Key: 213872802
• Report Number: 1119779-2020-00842
• 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,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/06/2020
• Device Catalogue Number: 256082
• Device Lot Number: 0198093
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention