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 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

Eua # (b)(4).Medical device lot #: 0248470 was reported, however, this is not a lot# manufactured for this product.Medical device expiration date: unknown.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 potential discrepant results were obtained.The patient was tested twice with different cartridges one tested positive the other was negative.It is unknown if confirmatory testing was performed.There was no report of patient impact.Eua # (b)(4).

Event Description

It was reported while testing for sars-cov-2 potential discrepant results were obtained.The patient was tested twice with different cartridges one tested positive the other was negative.It is unknown if confirmatory testing was performed.There was no report of patient impact.Eua # (b)(4).

Manufacturer Narrative

Investigation: bd has received several customer complaints for false positive results, when using bd sars-cov-2 reagents for bd veritor¿ system.The current investigation concerns multiple lots of bd sars-cov-2 reagents for bd veritor¿ system.Bd takes a systematic approach to investigating false positive complaints that are received.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples (if applicable).The batch history records were reviewed and no discrepancies were noted.Functional analysis of retention materials met acceptance criteria.No returns were received to investigate.Quality was unable to duplicate the customers reported failure mode.Complaint trending review reveals a trend in customer complaints related to false positive results, when using bd sars-cov-2 reagents for bd veritor¿ system.Although the investigation was not confirmed, based on the complaint trend, a corrective and preventive action (capa#1878253) was initiated to determine root cause(s).Bd point of care will continue to closely monitor for trends associated with false positive or discrepant results when using the kit bd veritor for rapid detection of sars-cov-2.There was no corrective action 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: 11304691
• MDR Text Key: 242064428
• Report Number: 1119779-2021-00281
• 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: 08/27/2021

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: Other
• Device Catalogue Number: 256082
• Device Lot Number: 0248470
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1