MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VERITOR PLUS ANALYZER; SEE H.10

Model Number 256066

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2023

Event Type  malfunction  

Manufacturer Narrative

D.3 common device name: antigens, all groups, streptococcus spp.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using bd veritor plus analyzer that there was discrepant results.The following information was provided by the initial reporter: hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details did erroneous results occur? yes.Customer reporting discrepant results from analyzer.Customer is questioning the accuracy of the analyzer.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2023-00418 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.H3 other text : see h.10.

Event Description

It was reported that while using bd veritor plus analyzer that there was discrepant results the following information was provided by the initial reporter: hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details did erroneous results occur? yes.Customer reporting discrepant results from analyzer.Customer is questioning the accuracy of the analyzer.

• Brand Name: BD VERITOR PLUS ANALYZER
• Type of Device: SEE H.10
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16740459
• MDR Text Key: 313342705
• Report Number: 1119779-2023-00418
• Device Sequence Number: 1
• Product Code: JJQ
• UDI-Device Identifier: 00382902560661
• UDI-Public: 00382902560661
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

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 Model Number: 256066
• Device Catalogue Number: 256066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1