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

Catalog Number 256045

Device Problem False Negative Result (1225)

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

Event Date 09/22/2023

Event Type  Injury  

Event Description

It was reported that while using bd veritor¿ system for rapid detection of flu a+b clia-waved kit false negative occurred.The following information was provided by the initial reporter: customer states specimen was positive for flu a when they visually read the test device but negative when it was inserted in the analyzer.Per customer, patient is symptomatic and provider decided to treat patient.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated: b1.Adverse type: reported issue is both an adverse event and product problem.D9.Device available for evaluation? yes.Returned to manufacturer on: 04-oct-2023.H1.Type of reportable event: serious injury.H6.Investigation summary: this statement is to summarize the investigation results regarding the complaint that alleges ¿false negative result¿ when using kit flu a+b 30 test physician veritor (material # 256045), batch number 2175875.The customer reported that the specimen was positive for flu a when they visually read the test device but negative when it was inserted in the analyzer.Per customer, the patient was symptomatic, and provider decided to treat the patient.During trouble shooting, the customer stated that they performed verification cartridge and it passed.Per customer, they always read the test devices visually.Bd quality performs a systematic approach to investigate false negative result complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.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.Testing was performed on the kit returned and all the devices tested had intended results.No issue was identified.Based on the information provided, the customer tried to interpret the test result visually.Bd representative advised the customer that this test is not designed to read visually.The complaint was unable to be confirmed.A trend analysis for false negative was conducted, no adverse trend was identified.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.

• 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): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17944545
• MDR Text Key: 326007024
• Report Number: 3006948883-2023-00107
• Device Sequence Number: 1
• Product Code: GNX
• UDI-Device Identifier: 00382902560456
• UDI-Public: (01)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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256045
• Device Lot Number: 2175875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention