MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT; ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C

Model Number 256045

Device Problem False Positive Result (1227)

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

Event Date 12/21/2022

Event Type  malfunction  

Event Description

It was reported that bd veritor¿ system for rapid detection of flu a+b clia-waved kit obtained a 3 false positive after retesting with the same lot.No injuries were reported.The following information was provided by the initial reporter: customer is reporting 3 instance of false positives with same lot but the samples were re-tested with another test cartridge which resulted in negative.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd veritor¿ system for rapid detection of flu a+b clia-waved kit obtained a 3 false positive after retesting with the same lot.No injuries were reported.The following information was provided by the initial reporter: customer is reporting 3 instance of false positives with same lot but the samples were re-tested with another test cartridge which resulted in negative.

Manufacturer Narrative

H.6 investigation summary: this statement is to summarize the investigation results regarding the complaint that alleges ¿false positive result¿ when using kit flu a+b 30 test physician veritor (material # 256045), batch number 2299095.Bd quality performs a systematic approach to investigate false positive result complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Based on the available information understood that analyzer showed positive for the first test cartridge, but customer doubt the result when seeing no lines visually.Customer re-test the samples by taking a new swab and testing with another test cartridge, the result shown in analyzer was negative.Bhr (batch history review) analysis and retain sample testing were performed on the batch number provided and no issues were found, and results were acceptable.Samples were returned for investigation.Upon visual inspection, the returned kit is missing the extraction reagent pouches, control swabs, and devices.Customer had returned six used tested devices and placed them in a biohazard red bag.Based on the returned samples the return sample analysis could not be performed.A trend analysis for false positive was conducted, no adverse trend was identified.The complaint was unable to be confirmed.The root cause could not be identified.Bd quality will continue to monitor for trends.H3 other text : see h.10.

• Brand Name: BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
• Type of Device: ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16141976
• MDR Text Key: 308079897
• Report Number: 1119779-2023-00015
• Device Sequence Number: 1
• Product Code: GNX
• UDI-Device Identifier: 00382902560456
• UDI-Public: 00382902560456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132692
• 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: 03/07/2023

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: 256045
• Device Catalogue Number: 256045
• Device Lot Number: 2299095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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