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 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Initial reporter address: the initial reported address was not provided.The bd (b)(4) address is being used.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 three (3) false positive results were obtained.The samples were repeated on the veritor and pcr method and upon repeat the results were negative.There was no indication that results were reported out or any report of patient impact.(b)(4).

Event Description

It was reported while testing for sars cov-2 three (3) false positive results were obtained.The samples were repeated on the veritor and pcr method and upon repeat the results were negative.There was no indication that results were reported out or any report of patient impact.(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 investigation did not find a root cause for the false positive results that were observed.Bd cannot confirm the complaint based on the investigation that was performed.A corrective and preventive action (capa#1878253) is already initiated to investigate the root cause and some mitigation actions are already being addressed.

• 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: 11060826
• MDR Text Key: 225135209
• Report Number: 1119779-2020-01271
• 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: 04/29/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1