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

Model Number 256038

Device Problem False Positive Result (1227)

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

Event Date 06/09/2022

Event Type  malfunction  

Event Description

It was reported that while using kit rsv 30 test physician veritor the customer received false positive results.A confirmatory pcr test performed on the same day produced negative results.This event occurred 1 time(s).There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "customer reports false positive rsv result on kit "256038" lot # 1294741", "customer had 1 test come back as positive on the veritor but it was negative with confirmation test "pcr".Customer says the confirmation tests were done on the same day.".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: this statement summarizes the investigation results regarding your complaint that alleges false positive when using kit rsv 30 test physician veritor (material # 256038), batch numbers 1294741.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.Bhr and retain sample testing were performed on the batch number provided and no relevant issue was found.The complaint was unable to be confirmed via the retain samples.Quality did not receive physical samples and sample analysis did not occur.If samples are received at a later date, the complaint may be reopened.A trend analysis for false positive was conducted, no adverse trend was identified.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.

Event Description

It was reported that while using kit rsv 30 test physician veritor the customer received false positive results.A confirmatory pcr test performed on the same day produced negative results.This event occurred 1 time(s).There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: "customer reports false positive rsv result on kit "256038" lot # 1294741", "customer had 1 test come back as positive on the veritor but it was negative with confirmation test "pcr".Customer says the confirmation tests were done on the same day.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14958788
• MDR Text Key: 301728395
• Report Number: 3006948883-2022-00142
• Device Sequence Number: 1
• Product Code: GQG
• UDI-Device Identifier: 00382902560388
• UDI-Public: 00382902560388
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

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
• Device Operator: Other
• Device Model Number: 256038
• Device Catalogue Number: 256038
• Device Lot Number: 1294741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 12/11/2022
• 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