MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) 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 04/25/2022

Event Type  malfunction  

Event Description

It was reported that while testing with the kit rsv 30 test physician veritor, a false positive result was obtained.Confirmatory testing was performed, and the result was negative.There was no report of patient impact.The following information was provided by the initial reporter: customer report 1 erroneous result when performing rsv test.¿ was individual symptomatic or asymptomatic? the patients had congestions and runny noses and afebriles.¿ how was it determined to be discrepant? we sent another samples to the lab (parkway labs) they run it for two days in there system and it came back with a negative result.¿ comparison to another method? parkway labs method vs bd veritor methology and both uses nasalpharyngeal swabs to obtain the samples.¿ was the cartridge rerun (re-read)? yes, just to make sure that we have the same result.

Manufacturer Narrative

Medical device lot #: 1285854 with expiration date 20-sep-2024 was reported, however, this is not a lot number manufactured for the reported catalog number.Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while testing with the kit rsv 30 test physician veritor, a false positive result was obtained.Confirmatory testing was performed, and the result was negative.There was no report of patient impact.The following information was provided by the initial reporter: customer report 1 erroneous result when performing rsv test was individual symptomatic or asymptomatic? the patients had congestions and runny noses and afebriles how was it determined to be discrepant?¿ we sent another samples to the lab (parkway labs) they run it for two days in there system and it came back with a negative result.Comparison to another method? parkway labs method vs bd veritor methology and both uses nasopharyngeal swabs to obtain the samples.Was the cartridge rerun (re-read)? yes just to make sure that we have the same result.

Manufacturer Narrative

H.6 investigation summary: this summarizes the investigation results regarding a complaint that alleges the bd veritor at home covid-19 test (material # 256094), batch number unknown, ¿had a positive result however the test from parkway lab was negative.¿ bd quality performs a systematic approach to investigate all 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 return testing were performed with no issues identified.Results were acceptable and no relevant issue was found.The complaint was unable to be confirmed.The root cause could not be identified.Currently, there are no adverse trends identified for false positive.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.

Manufacturer Narrative

H.6 investigation summary: this summarizes the investigation results regarding a complaint that alleges the bd veritor at home covid-19 test (material # 256094), batch number unknown, ¿had a positive result however the test from parkway lab was negative.¿ bd quality performs a systematic approach to investigate all 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 return testing were performed with no issues identified.Initially batch number was unknown but return sample from customer confirm batch number is 1294741.Results were acceptable and no relevant issue was found.The complaint was unable to be confirmed.The root cause could not be identified.Currently, there are no adverse trends identified for false positive.

Event Description

It was reported that while testing with the kit rsv 30 test physician veritor, a false positive result was obtained.Confirmatory testing was performed, and the result was negative.There was no report of patient impact.The following information was provided by the initial reporter: customer report 1 erroneous result when performing rsv test.Was individual symptomatic or asymptomatic? the patients had congestions and runny noses and afebriles.How was it determined to be discrepant? we sent another samples to the lab (parkway labs) they run it for two days in there system and it came back with a negative result.Comparison to another method? parkway labs method vs bd veritor methology and both uses nasalpharyngeal swabs to obtain the samples.Was the cartridge rerun (re-read)? yes just to make sure that we have the same result.

• Brand Name: KIT RSV 30 TEST PHYSICIAN VERITOR
• Type of Device: ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14639503
• MDR Text Key: 302797881
• Report Number: 1119779-2022-00838
• 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,Followup
• Report Date: 01/11/2023

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 Model Number: 256038
• Device Catalogue Number: 256038
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 10/03/2022; 01/11/2023
• Supplement Dates FDA Received: 10/07/2022; 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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