MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) SEE H.10

Model Number 256045

Device Problem False Positive Result (1227)

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

Event Date 03/09/2023

Event Type  malfunction  

Manufacturer Narrative

Medical device brand name:bd veritor¿ system for rapid detection of flu a+b clia-waved kit.Common device name:antigens, cf (including cf control), influenza virus a, b, c initial reporter address: col cuauhtemoc av del bosque 139 a device evaluation and/or device history review is antici.Pated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd veritor¿ system for rapid detection of flu a+b clia-waved kit 80% of results obtain positive results.The following information was provided by the initial reporter: the client comments that when using the cartridges for the influenza test with veritor, 80% of the results obtained have been positive for influenza type b.The test can analyze both influenza a and b but they have noticed a marked bias towards type b positivity.They are concerned that the veritor cartridge is failing because this marked tendency to type b does not seem logical to them.Quality control of each kit, with positive control and negative control, has been satisfactory.They started using a new kit and with a different reader and so far have not noticed a bias.The client asks to know if the batch is working well, if there have been any other reports.

Event Description

It was reported that bd veritor¿ system for rapid detection of flu a+b clia-waved kit 80% of results obtain positive results.The following information was provided by the initial reporter: the client comments that when using the cartridges for the influenza test with veritor, 80% of the results obtained have been positive for influenza type b.The test can analyze both influenza a and b but they have noticed a marked bias towards type b positivity.They are concerned that the veritor cartridge is failing because this marked tendency to type b does not seem logical to them.Quality control of each kit, with positive control and negative control, has been satisfactory.They started using a new kit and with a different reader and so far have not noticed a bias.The client asks to know if the batch is working well, if there have been any other reports.

Manufacturer Narrative

H.6 investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges received discrepant results when using kit rapid detection of kit flu a+b 30 test physician veritor (material # 256045), batch number 2269666."customer informed that when using the cartridges for the influenza test with veritor, 80% of the results obtained have been positive for influenza type b.The test can analyze both influenza a and b, but they have noticed a marked bias towards type b positivity.They are concerned that the veritor cartridge is failing because this marked tendency to type b does not seem logical to them".Bd quality performs a systematic approach to investigate discrepant result complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation (bhr analysis and retain sample analysis) was performed on the batch number provided and results were acceptable, no relevant issue was found.No return samples were received; therefore, no return sample analysis could be performed.However, customer had returned photographs and reported issue was unable to confirm based on the photographs had provided.The reported issue was unable to be confirmed.The root cause was identified as cause traced to user.Currently no adverse trend identified for discrepant result.Bd quality will continue to closely monitor for trends.

• Brand Name: SEE H.10
• Type of Device: SEE H.10
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16599347
• MDR Text Key: 312307722
• Report Number: 1119779-2023-00325
• Device Sequence Number: 1
• Product Code: GNX
• UDI-Device Identifier: 00382902560456
• UDI-Public: 00382902560456
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K132692
• 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: 04/24/2023

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: 256045
• Device Catalogue Number: 256045
• Device Lot Number: 2269666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• 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