MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VERITOR¿ PLUS ANALYZER; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Model Number 256066

Device Problem False Positive Result (1227)

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

Event Date 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.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 the bd veritor¿ plus analyzer produced 2 false positive results while running the flu test kits.Nasopharyngeal swabs were sent to another location to rerun the tests on another veritor, which came back as negative.There was no indication that results were reported, and there was no report of patient impact.This complaint was created to capture the 2nd of 5 related incidents.The following information was provided by the initial reporter: "customer called to report 19 false positive test results when running their 256041 flu a+b test kits from lot 0051984." "is the customer reporting a false positive or false negative? 19 false positives did the customer visually interpret the result or did they insert into the analyzer to determine the result? analyzer read.What type of reference method was used to confirm the result (pcr, viral culture, etc)? customer is only reporting confirming the test with another veritor analyzer run off the same sample.They did not see a positive line on any of the reported false positive cartridges.Customer understands visually interoperated results are not valid.No pcr based confirmatory tests were done.Because no flu has been reported in their area they believe the original positive result was incorrect, but the only confirmation they have is the second veritor test ran in duplicate on same specimen with new test cartridge on different analyzer.How many specimens were discrepant (fp or fn)? 19 false positives.Was the patient(s) symptomatic when tested on the veritor plus analyzer: customer unable to provide.Were patients symptomatic or asymptomatic? customer does not have that information but assumes they had some type of symptoms"."customer is alleging 19 false positive test results when running 256041 test kit.They ran the test from the collected nasopharyngeal swab that was in vtm and it was positive on the veritor analyzer.They did not visually see any positive line on the test cartridges.They sent the swabs to their other location to run the tests on another veritor at that site.The results came up as negative.After they had so many false positive test results they stated they decided to toss the analyzer because they were not comfortable using it anymore and the customer states it was old.Customer found veritor and this case was opened to document issue under veritor serial number because of high rate of false results.False positives were obtained on following days, (b)(6) 2021 2 false positives, (b)(6) 2021 2 false positives, (b)(6) 2021 3 false positives, (b)(6) 2021 2 false positives, and (b)(6) 2021 10 false positives.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 02-dec-2021 h.6.Investigation: the complaint was created for false positive issues on the bd veritor plus analyzer (p/n 256066, s/n (b)(6)).The customer reported multiple false positive on the analyzer.The device history record for bd veritor plus analyzer, sn (b)(6), was examined and showed no discrepancies relate to this issue that can be correlated to this complaint.The reader passed all tests including the final assembly process, oqa, source inspection, functionality, final packing test and manual inspection.The veritor plus analyzer, sn (b)(6), was returned for investigation.Was returned for investigation.The analyzer was tested with a verification cartridge and the result was passing.The returned analyzer was also tested with calibration cartridges that ranged from the faintest lines to the darkest lines that the reader was designed to detect.A review of those data showed the analyzer is functioning within specification.Based on this evidence the complaint is unconfirmed.Bd quality will continue to monitor for trends related to the veritor system.

Event Description

It was reported that the bd veritor¿ plus analyzer produced 2 false positive results while running the flu test kits.Nasopharygeal swabs were sent to another location to rerun the tests on another veritor, which came back as negative.There was no indication that results were reported, and there was no report of patient impact.This complaint was created to capture the 2nd of 5 related incidents.The following information was provided by the initial reporter: "customer called to report 19 false positive test results when running their 256041 flu a+b test kits from lot 0051984." "is the customer reporting a false positive or false negative? 19 false positives did the customer visually interpret the result or did they insert into the analyzer to determine the result? analyzer read what type of reference method was used to confirm the result (pcr, viral culture, etc)? customer is only reporting confirming the test with another veritor analyzer run off the same sample.They did not see a positive line on any of the reported false positive cartridges.Customer understands visually interperated results are not valid.No pcr based confirmatory tests were done.Because no flu has been reported in their area they believe the original positive result was incorrect, but the only confirmation they have is the second veritor test ran in duplicate on same specimen with new test cartridge on different analyzer.How many specimens were discrepant (fp or fn)? 19 false positives was the patient(s) symptomatic when tested on the veritor plus analyzer: customer unable to provdide were patients symptomatic or asymptomatic? customer does not have that information but assumes they had some type of symptoms" "customer is alleging 19 false positive test results when running 256041 test kit.They ran the test from the collected nasopharygeal swab that was in vtm and it was positive on the veritor analyzer.They did not visually see any positive line on the test cartridges.They sent the swabs to their other location to run the tests on another veritor at that site.The results came up as negative.After they had so many false positive test results they stated they decided to toss the analyzer because they were not comfortable using it anymore and the customer states it was old.Customer found veritor and this case was opened to document issue under veritor serial number because of high rate of false results.False positives were obtained on following days, nov/03/2021 2 false positives, nov/05/2021 2 false positives, nov/06/2021 3 false positives, nov/07/2021 2 false positives, and nov/09/2021 10 false positives.".

• Brand Name: BD VERITOR¿ PLUS ANALYZER
• Type of Device: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
• 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: 13022994
• MDR Text Key: 289100925
• Report Number: 1119779-2021-01984
• Device Sequence Number: 1
• Product Code: GTY
• UDI-Device Identifier: 00382902560661
• UDI-Public: 00382902560661
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180438
• 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: 05/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 256066
• Device Catalogue Number: 256066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1