MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 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 05/18/2022

Event Type  malfunction  

Event Description

It was reported while testing with bd veritor¿ system for rapid detection of flu a+b clia-waved kit customer visually inspected the device and questioned the result.There was no indication that results were reported out, and there was no report of patient impact.The following information was provided by the initial reporter: customer performed the test on may 18th and reported it on 6/7th.It was reported by the customer that they got an invalid result on flu kit.Customer problem: got this complaint in the email from "bd rep".Customer reports invalid result on flu kit.Customer got a positive flu b result on asymptomatic patient 5/28th/22 and she is questioning the results.Lot# 0133527 steps taken with customer/troubleshooting: called the customer and verified if she actually got an invalid result.Customer explains that she got a positive flu b result on asymptomatic patient and she is questioning the result since the test device show streaks and the background was pinkish which may states that the specimen didn't flow completely in the test device and that 's why customer thinks that the result is invalid.Quantity received and quantity affected: 3 if consumable is tested on bd instrumentation, list serial numbers: (b)(4).Got this complaint in the email from evan woodward "bd rep".Customer reports invalid result on flu kit.

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

H.6 investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges discrepant result when using kit rapid detection of kit flu a+b 30 test physician veritor (material # 256045), batch number 0133527.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 and testing were performed on the batch number provided and no relevant issue was found.The reported issue was unable to be confirmed.The root cause could not be identified.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 while testing with bd veritor¿ system for rapid detection of flu a+b clia-waved kit customer visually inspected the device and questioned the result.There was no indication that results were reported out, and there was no report of patient impact.The following information was provided by the initial reporter: customer performed the test on may 18th and reported it on 6/7th.It was reported by the customer that they got an invalid result on flu kit.Customer problem: got this complaint in the email from "bd rep".Customer reports invalid result on flu kit.Customer got a positive flu b result on asymptomatic patient (b)(6) 2022 and she is questioning the results.Lot# 0133527 steps taken with customer/troubleshooting: called the customer and verified if she actually got an invalid result.Customer explains that she got a positive flu b result on asymptomatic patient and she is questioning the result since the test device show streaks and the background was pinkish which may states that the specimen didn't flow completely in the test device and that 's why customer thinks that the result is invalid.Quantity received and quantity affected: 3 if consumable is tested on bd instrumentation, list serial numbers: (b)(6).Got this complaint in the email from evan woodward "bd rep".Customer reports invalid result on flu kit.

• 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): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14919028
• MDR Text Key: 297158700
• Report Number: 3006948883-2022-00138
• 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: K160161
• 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: 11/16/2022

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: 04/26/2023
• Device Model Number: 256045
• Device Catalogue Number: 256045
• Device Lot Number: 0133527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 07/05/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2020
• 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