MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT; ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C

Model Number 256045

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/24/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd veritor¿ system for rapid detection of flu a+b clia-waved kit discrepant result occurred.The following information is provided by the initial reporter: " customer states they received discrepant results hazard, injury or erroneous results? yes hazard, injury or erroneous results details detailed erroneous results (include # of errors and type): discrepant results what result did the customer obtain from the bd product? customer obtained neg result on initial run what result was the customer expecting to obtain (if different from the obtained result) customer suspected pos results, was this a qc, validation, or proficiency test? patient testing was patient treatment changed as a consequence of the issue with results? yes did the patient suffer any adverse medical consequences as a result of the change in treatment? unknown".

Manufacturer Narrative

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 0321884.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) was performed on the batch number provided and no relevant issue was found.The retain sample analysis were not performed due to the discrepancy was found to be caused by user error.Communicated to the customer that cartridges are never to be read visually it can be only analyzed by bd veritor analyzer.Review of risk management documentation indicates that the potential risk of the reported complaint (discrepant results) was assessed as severity s3 (reference line # 78) via document ra0002, rev 6.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.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 bd veritor¿ system for rapid detection of flu a+b clia-waved kit discrepant result occurred.The following information is provided by the initial reporter: " customer states they received discrepant results hazard, injury or erroneous results? yes hazard, injury or erroneous results details detailed erroneous results (include # of errors and type): discrepant results what result did the customer obtain from the bd product? customer obtained neg result on initial run what result was the customer expecting to obtain (if different from the obtained result) customer suspected pos results, was this a qc, validation, or proficiency test? patient testing was patient treatment changed as a consequence of the issue with results? yes did the patient suffer any adverse medical consequences as a result of the change in treatment? unknown".

• Brand Name: BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
• Type of Device: ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C
• 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: 15739922
• MDR Text Key: 307030713
• Report Number: 1119779-2022-01364
• Device Sequence Number: 1
• Product Code: GNX
• UDI-Device Identifier: 00382902560456
• UDI-Public: 00382902560456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132692
• 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: 12/05/2022

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 Expiration Date: 10/25/2023
• Device Model Number: 256045
• Device Catalogue Number: 256045
• Device Lot Number: 0321884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• 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