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 10/16/2022

Event Type  malfunction  

Event Description

It was reported that while using bd veritor¿ system for rapid detection of flu a+b clia-waved kit discrepant results occurred.The following information was provided by the initial reporter: "customer reported discrepant result using the veritor analyzer.Customer ran the test twice and obtained positive result first, and then negative.".

Manufacturer Narrative

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

Manufacturer Narrative

Investigation summary: this statement is to summarize the investigation results regarding the complaint that alleges ¿discrepant result¿ when using kit flu a+b 30 test physician veritor (material # 256045), batch number unknown.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.Based on the provided information, understood that the customer re-inserted the test cartridge again after the recommended time, so they received discrepant result.Review of risk management documentation indicates that the potential risk of the reported complaint (discrepant result) was assessed as severity s1 (reference line # 94) via document ra0002, rev 6.Batch history record (bhr) review and retain sample testing could not be performed as no batch number was provided.The complaint was unable to be confirmed.The root cause could not be identified.There are no current trends against discrepant result.Bd quality will continue to closely 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 bd veritor¿ system for rapid detection of flu a+b clia-waved kit discrepant results occurred.The following information was provided by the initial reporter: "customer reported discrepant result using the veritor analyzer.Customer ran the test twice and obtained positive result first, and then negative.".

• 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: 15667889
• MDR Text Key: 307026616
• Report Number: 1119779-2022-01335
• 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: 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: 256045
• Device Catalogue Number: 256045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 12/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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