MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. KIT RSV 30 TEST PHYSICIAN VERITOR; ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS

Catalog Number	256038
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	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the kit rsv 30 test physician veritor the user visually inspects the cartridge and questions the result when three lines instead of two was observed.The reader provided a negative result.No health impact or consequence reported.
Additional Manufacturer Narrative
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
H.6.Investigation summary: this summarizes the investigation results regarding a complaint that alleges discrepant result when using kit rsv 30 test physician veritor (material #: 256038), batch number 2262173.It was reported by the customer that they obtained a discrepant result for a patient sample.According to the customer, they observed 3 lines instead of 2, while the instrument reports a negative result.After reinserting the cartridge 3 times, the instrument reports positive results.Bd quality performed a systematic approach to investigate discrepant result 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.This complaint was unable to be confirmed.No trend against discrepant result was identified.Bd quality will continue to closely monitor for trends.There were no corrective actions taken at this time h3 other text : see h.10.
Event or Problem Description
It was reported when using the kit rsv 30 test physician veritor the user visually inspects the cartridge and questions the result when three lines instead of two was observed.The reader provided a negative result.No health impact or consequence reported.

• Brand Name: KIT RSV 30 TEST PHYSICIAN VERITOR
• Common Device Name: ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS
• 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: 18250857
• Report Number: 3006948883-2023-00122
• Device Sequence Number: 12407745
• Product Code: GQG
• UDI-Device Identifier: 00382902560388
• UDI-Public: (01)00382902560388
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K132456
• 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): 04/05/2024

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: 08/26/2025
• Device Catalogue Number: 256038
• Device Lot Number: 2262173
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• 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