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 Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/30/2023

Event Type  malfunction  

Manufacturer Narrative

E.1initial reporter e-mail: (b)(6).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¿ system for rapid detection of flu a+b clia-waved kit that there was discrepant results.The following information was provided by the initial reporter: total quantity of product showing defect: 3 kit ver 256045_2333594 - discrepant results.

Event Description

It was reported that while using bd veritor¿ system for rapid detection of flu a+b clia-waved kit that there was discrepant results.The following information was provided by the initial reporter: total quantity of product showing defect: 3 kit ver 256045_2333594 - discrepant results.

Manufacturer Narrative

H.6.Investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges discrepant results when using kit rapid detection of kit flu a+b 30 test physician veritor (material # 256045), batch number 2333594.The customer reported discrepant results with flu kit and no further information was provided.During a follow up, the customer stated that the readings are accurate at this point.Bd quality performs a systematic approach to investigate discrepant 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.The results were acceptable, and no relevant issues were found.No photos or physical samples were received; therefore, no return sample analysis could be performed.This complaint was unable to be confirmed.The root cause could not be determined.Currently no adverse trend identified for the reported issue.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.

• 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: 17782610
• MDR Text Key: 323854845
• Report Number: 3006948883-2023-00099
• Device Sequence Number: 1
• Product Code: GNX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160161
• 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: 11/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256045
• Device Lot Number: 2333594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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