MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR SYSTEM FOR RAPID DETECTION OF RSV; RESPIRATORY SYNCYTIAL VIRUS ANTIGEN, CF

Model Number	256042
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 was reported that a false positive result for flu a and rsv was produced by the bd veritor system for rapid detection of rsv.Confirmatory testing was not performed, and clinicians were not notified of the erroneous results.There was also no report of adverse patient impact.The following information was provided by the initial reporter: "false positive result not confirmed by real time pcr false positive result for a clinical sample, nasopharyngeal swab in nacl 0,9% from a patient.Not confirmed by real time pcr.Visual inspection of the veritor device showed a very light line which was interpreted by the veritor plus analyse as positive.The same sample was tested false positive for rsv, also not confirmed by real time pcr.Patient was sars-cov 2 negative" "no incorrect results were reported" " same sample (from the same patient) was false positive for flua and rsv only when a sample is positive for both flua & rsv, with a weak line, a pcr test is performed for confirmation.Also for this case , the clinical symptoms were not correlating with a positive result for flua and rsv".
Additional Manufacturer Narrative
H6: investigation summary this statement is to summarize the investigation results regarding your complaint that alleges false positive results when using kit rsv 30 test hospital veritor (material # 256042), batch number 9301451.Bd quality performs a systematic approach to investigate false positive complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation and testing were performed on the batch number provided.The reported was unable to be confirmed.The root cause could not be identified.Bd quality will continue to closely monitor for trends.H3 other text : see h10.
Event or Problem Description
It was reported that a false positive result for flu a and rsv was produced by the bd veritor system for rapid detection of rsv.Confirmatory testing was not performed, and clinicians were not notified of the erroneous results.There was also no report of adverse patient impact.The following information was provided by the initial reporter: "false positive result not confirmed by real time pcr false positive result for a clinical sample, nasopharyngeal swab in nacl 0,9% from a patient.Not confirmed by real time pcr.Visual inspection of the veritor device showed a very light line which was interpreted by the veritor plus analyse as positive.The same sample was tested false positive for rsv, also not confirmed by real time pcr.Patient was sars-cov 2 negative." "no incorrect results were reported." same sample (from the same patient) was false positive for flua and rsv.Only when a sample is positive for both flua & rsv , with a weak line, a pcr test is performed for confirmation.Also for this case , the clinical symptons were not correlating with a positive result for flua and rsv.

• Brand Name: BD VERITOR SYSTEM FOR RAPID DETECTION OF RSV
• Common Device Name: RESPIRATORY SYNCYTIAL VIRUS ANTIGEN, CF
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12760763
• Report Number: 3006948883-2021-00994
• Device Sequence Number: 3144840
• Product Code: GQG
• UDI-Device Identifier: 00382902560425
• UDI-Public: 00382902560425
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K133140
• 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): 01/20/2022

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: 05/20/2022
• Device Model Number: 256042
• Device Catalogue Number: 256042
• Device Lot Number: 9301451
• 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: 10/11/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2019
• 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