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	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that kit rsv 30 test physician veritor discrepant results compared to pcr results.No patient impact was reported.The following information was provided by the initial reporter: discrepancy in the results of rapid respiratory virus tests (rsv and flu) versus the pcr results performed by bd max.Rapid tests were performed on nasopharyngeal swabs.For vsr, the bd veritor system clia kit was used, lot: 1294669 and expiration date: 09-20-2024.For flu, the bd veritor system clia kit was used, lot: 2292271 and expiration date: 10-12-2025.Pcr was performed on nasopharyngeal aspirates using the bd max sars-cov2/flu kit, lot 2270730 and expiration date: 05-12/2023.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Further information was provided by the customer which indicated that the device performed as intended; they are no longer alleging any defect with the product.There was no report of serious injury, medical intervention, or reportable device malfunction.The previous mfr report #3014704491-2023-00444 should be considered cancelled.
Event or Problem Description
It was reported that kit rsv 30 test physician veritor discrepant results compared to pcr results.No patient impact was reported.The following information was provided by the initial reporter: discrepancy in the results of rapid respiratory virus tests (rsv and flu) versus the pcr results performed by bd max.Rapid tests were performed on nasopharyngeal swabs.For vsr, the bd veritor system clia kit was used, lot: 1294669 and expiration date: 09-20-2024.For flu, the bd veritor system clia kit was used, lot: 2292271 and expiration date: 10-12-2025.Pcr was performed on nasopharyngeal aspirates using the bd max sars-cov2/flu kit, lot 2270730 and expiration date: 05-12/2023.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17507412
• Report Number: 3014704491-2023-00444
• Device Sequence Number: 6496311
• Product Code: GQG
• UDI-Device Identifier: 00382902560388
• UDI-Public: 00382902560388
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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 Expiration Date: 09/20/2024
• Device Catalogue Number: 256038
• Device Lot Number: 1294669
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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