MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VERITOR PLUS ANALYZER; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Catalog Number 256066

Device Problem False Positive Result (1227)

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

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

H3.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 during use with the bd veritor plus analyzer, a result was displayed positive for both flu a and flu b and the analyzer did not display "invalid".There was no report of patient impact.

Event Description

It was reported that during use with the bd veritor plus analyzer, a result was displayed positive for both flu a and flu b and the analyzer did not display "invalid".There was no report of patient impact.

Manufacturer Narrative

H.6 investigation summary this complaint alleges the bd veritor plus analyzer shows both positive flu a and b (catalog number 256066, serial number (b)(6)).It was reported by the customer that a patient specimen showed a positive result for both flu a and b on the veritor analyzer, but the analyzer did not give an error indicating the result was invalid.Customer did not provide any further information or perform any troubleshooting with technical service (ts).The complaint is unconfirmed.Dhr for veritor plus analyzer, serial number (b)(6)was reviewed and nonconformances related to this failure mode were not revealed in manufacturing during final testing.The device was released conforming.Quality did not receive samples for this complaint and therefore returned sample analysis could not occur.If samples are received at a later date, the complaint may be reopened.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.

• Brand Name: BD VERITOR PLUS ANALYZER
• Type of Device: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18334747
• MDR Text Key: 330598416
• Report Number: 1119779-2023-01372
• Device Sequence Number: 1
• Product Code: JJQ
• UDI-Device Identifier: 00382902560661
• UDI-Public: (01)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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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