MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. KIT FLU A+B 30 TEST HOSPITAL VERITOR; DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS

Catalog Number	256041
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple pma/510k numbers.The information for each additional pma/510k is as follows: g.5.Pma / 510(k)#: k132259, k132692, k151291, k152870, k160161 k121797, k132256, k132693, k133138, k151301, k152874, k160164 h.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It is reported that during use of the bd veritor¿ system for rapid detection of flu a+b clia-waved kit, three 3 lines appeared on test cartridge: control, flu a, and line below flu a.Test was read on veritor and flu a positive was the result.There was no report of patient impact.
Additional Manufacturer Narrative
H.6 investigation summary this statement summarizes the investigation results regarding a complaint that alleges erroneous result when using bd veritor¿ flu a+b kit (material#: 256041), batch number 3035676.The customer reported that they visually saw 3 lines on the test cartridge, control line, flu a, and another line under flu a, but when read on the veritor analyzer, the result was flu a positive.They reported not trusting the result.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 samples were received; therefore, return sample analysis could not be performed.However, a photograph was returned that showed 3 lines on the test cartridge.The reported issue was unable to be confirmed.A trend analysis for erroneous result was conducted, no adverse trend was identified.The customer was informed that test cartridges should not be read visually and to always use the analyzer to receive results.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 is reported that during use of the bd veritor¿ system for rapid detection of flu a+b clia-waved kit, three 3 lines appeared on test cartridge: control, flu a, and line below flu a.Test was read on veritor and flu a positive was the result.There was no report of patient impact.

• Brand Name: KIT FLU A+B 30 TEST HOSPITAL VERITOR
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18499428
• Report Number: 3006948883-2023-00147
• Device Sequence Number: 7863872
• Product Code: PSZ
• UDI-Device Identifier: 00382902560418
• UDI-Public: (01)00382902560418
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2024

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: 12/17/2025
• Device Catalogue Number: 256041
• Device Lot Number: 3035676
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2023
• 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