MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT; DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS

Catalog Number	256041
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using one (1) bd veritor¿ system for rapid detection of flu a+b laboratory kit, discrepant flu results were observed with an unspecified number of patient samples.Other non specified tests provided positive flu results.There were no health impact or consequences reported.No additional information was provided as the customer has not responded to multiple follow up attempts by bd.
Additional Manufacturer Narrative
There were multiple 510k reported to be involved.The information for the additional 510k are as follows: g.4.Pma/510(k)#: k121797, k132256, k132693, k133138, k151301, k152874, k160164.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: this statement summarizes the investigation results regarding a complaint that alleges discrepant result when using kit flu a+b 30 test hospital veritor (material #: 256041), batch number 3274402.The customer reported that they are receiving discrepant results.Bd quality performs a systematic approach to investigate all complaints.This approach involves review of manufacturing batch history records, visual inspection of retention samples, and visual inspection of customer returned samples, if applicable.Batch history record (bhr) review and retain sample testing were performed on the batch number provided.The results were acceptable, and no relevant issues were found.No photos or samples were received; therefore, return sample analysis could not be performed.The reported issue was unable to be confirmed.A trend analysis for discrepant result was conducted, no adverse trend was identified.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.
Event or Problem Description
It was reported when using one (1) bd veritor¿ system for rapid detection of flu a+b laboratory kit, discrepant flu results were observed with an unspecified number of patient samples.Other non specified tests provided positive flu results.There were no health impact or consequences reported.No additional information was provided as the customer has not responded to multiple follow up attempts by bd.

• Brand Name: BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT
• Common Device Name: DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21514986
• Report Number: 3006948883-2025-00005
• Device Sequence Number: 11887459
• Product Code: PSZ
• UDI-Device Identifier: 00382902560418
• UDI-Public: (01)00382902560418(11)231001(17)260406(10)3274402
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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
• Operator of Device: Other
• Device Expiration Date: 04/06/2026
• Device Catalogue Number: 256041
• Device Lot Number: 3274402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown