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

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2023

Event Type  malfunction  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 321636125
• Report Number: 3014704491-2023-00444
• Device Sequence Number: 1
• Product Code: GQG
• UDI-Device Identifier: 00382902560388
• UDI-Public: 00382902560388
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K132456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: 256038
• Device Lot Number: 1294669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1