MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD VERITOR PLUS ANALYZER; COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER

Catalog Number 256066

Device Problem False Negative Result (1225)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

Report 4 of 6.It was reported when using the bd veritor plus analyzer, false negative results for rsv were received.The rsv results were confirmed to be positive by pcr testing.There was no report of patient impact.

Manufacturer Narrative

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

Report 4 of 6.It was reported when using the bd veritor plus analyzer, false negative results for rsv were received.The rsv results were confirmed to be positive by pcr testing.There was no report of patient impact.

Manufacturer Narrative

Investigation summary: the complaint alleges the bd veritor plus analyzer provides discrepant results (catalog number 256066, serial number (b)(6).The customer said that the analyzer results showed as positive but visually the line showed positive.The results have been confirmed as positive by pcr.Issue has occurred with 6 patient samples.Customer was asked to insert the verification cartridge while on the phone and it passed.Customer is using walk-away mode on the analyzer.The discrepancies have occurred with the rsv test kit, multiple lots.The rma label was created to returned the defective unit, however, bd has not received the sample to be investigated.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.Review of risk management files confirms there are no new or modified risks associated with this failure mode.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: COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER
• 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: 18310288
• MDR Text Key: 330940450
• Report Number: 1119779-2023-01353
• 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: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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