MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD VERITOR ¿ SARS-COV-2 & FLU A+B

Catalog Number 256088

Device Problem False Positive Result (1227)

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

Event Date 10/04/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).H.3.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 the bd veritor ¿ sars-cov-2 & flu a+b -waved kit there was an alleged false positive flu a result on one patient sample.The following information was provided by the initial reporter: "alleged false positive flu a result.Test not repeated with left over fluid nor confirmatory test requested." (b)(4).

Manufacturer Narrative

The following fields have been updated with corrected and/or additional information: b.2.Describe event or problem: it was reported that while using the bd veritor ¿ sars-cov-2 & flu a+b there was an alleged false positive flu a result on one patient sample.The following information was provided by the initial reporter: "alleged false positive flu a result.Test not repeated with left over fluid nor confirmatory test requested." (b)(4).H.6.Investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges false positive results when using bd veritor¿ sars-cov-2 and flu a+b (material # 256088), batch numbers 2332350.The customer reported that they had one asymptomatic patient who tested positive for flu a recently and who has a history of testing positive for flu a every time tested on the veritor flu assay (for the past year).The customer stated that they followed the correct workflow, and the test device is not visually read.Their clinic performs verification cartridge daily and no issues to report.They have always tested the staff member with the triplex kit.According to the customer, the test was not repeated with a left-over fluid, nor was a confirmatory test requested.Bd quality performs a systematic approach to investigate false positive complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Batch history record (bhr) review and retain sample analysis were performed on the batch number provided.Results were acceptable and no relevant issue was found.No photos or samples were received; therefore, return sample analysis could not be performed.This complaint was unable to be confirmed.The root cause could not be identified.Currently no adverse trend for false positive was identified.Bd quality will continue to closely monitor for trends.

Event Description

It was reported that while using the bd veritor ¿ sars-cov-2 & flu a+b there was an alleged false positive flu a result on one patient sample.The following information was provided by the initial reporter: "alleged false positive flu a result.Test not repeated with left over fluid nor confirmatory test requested." (b)(4).

• Brand Name: BD VERITOR ¿ SARS-COV-2 & FLU A+B
• Type of Device: BD VERITOR ¿ SARS-COV-2 & FLU A+B
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18046355
• MDR Text Key: 327033316
• Report Number: 3014704491-2023-00683
• Device Sequence Number: 1
• Product Code: GNX
• UDI-Device Identifier: 00382902560456
• UDI-Public: (01)00382902560456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 12/21/2023

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 Expiration Date: 02/01/2024
• Device Catalogue Number: 256088
• Device Lot Number: 2332350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2024
• 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