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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the reader kit flu a+b 30 test hospital veritor the user visually inspects the cartridge and questions the result.The result was visually read positive for flu a+ and the analyzer gave a flu b+ result.No health impact or consequence reported.
Additional Manufacturer Narrative
Unknown lot number: d.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges discrepant result when using kit flu a+b 30 test hospital veritor (material # 256041), batch number unknown.The customer visually detected a positive result for flu a, but the analyzer gave a flu b+ result.They had some concerns about the differences between visual read and analyzer´s result.The customer confirmed that the results from the patient did not impact the treatment as it was reported as flu.Bd quality performs a systematic approach to investigate all discrepant result complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Batch history record (bhr) review and retain sample testing could not be performed because the batch number was not provided.No photos or physical samples were returned; therefore, return sample analysis could not be performed.According to the report, the customer tried to interpret the results visually.Bd representative advised the customer that this test is not designed to interpret the results visually and the results should only be read through analyzer.The reported issue was unable to be confirmed.Currently, there are no adverse trends identified for discrepant result.Bd quality will continue to monitor for trends.
Event or Problem Description
It was reported when using the reader kit flu a+b 30 test hospital veritor the user visually inspects the cartridge and questions the result.The result was visually read positive for flu a+ and the analyzer gave a flu b+ result.No health impact or consequence reported.

• 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: 18286970
• Report Number: 3006948883-2023-00126
• Device Sequence Number: 20500108
• Product Code: GNX
• UDI-Device Identifier: 00382902560418
• UDI-Public: (01)00382902560418
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K133138
• 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): 12/11/2023

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
• Operator of Device: Other
• Device Catalogue Number: 256041
• Device Lot Number: UNKNOWN
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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