MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR ¿ SARS-COV-2 & FLU A+B; NOT CLASSIFIED

Model Number 256040

Device Problem False Negative Result (1225)

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

Event Date 05/09/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd veritor ¿ sars-cov-2 & flu a+b that there was a false negative.The following information was provided by the initial reporter: customer responded confirming 4 fns she reported in her follow up email, and not the 10 reported originally.8.No erroneous patient results were reported hazard, injury or erroneous results? yes hazard, injury or erroneous results details customer reported discrepant results obtained on 2 analyzers.No erroneous results were reported, there is no patient impact.The correct diagnosis was made by an alternative method.

Manufacturer Narrative

E.7 initial reporter addr 1: (b)(6).H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: this statement is to summarize the investigation results regarding a complaint that involving kit grp a strep 30 test veritor (material # 256040), batch numbers 3012042.The customer reported that 4 false negative results were obtained from the bd veritor analyzer, and the samples were sent for culture test and found to be positive.During trouble shooting, the customer confirmed that they followed the correct workflow.Bd quality performs a systematic approach to investigate all false negative 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 testing were performed on the batch number provided.The results were acceptable, and no relevant issues were identified.No photo or physical samples were returned; therefore, return sample analysis could not be performed.Currently no adverse trend for false negative was identified.This complaint was unable to be confirmed.

Event Description

It was reported that while using the bd veritor ¿ sars-cov-2 & flu a+b that there was a false negative.The following information was provided by the initial reporter: customer responded confirming 4 fns she reported in her follow up email, and not the 10 reported originally.8.No erroneous patient results were reported.Hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details customer reported discrepant results obtained on 2 analyzers.No erroneous results were reported, there is no patient impact.The correct diagnosis was made by an alternative method.

• Brand Name: BD VERITOR ¿ SARS-COV-2 & FLU A+B
• Type of Device: NOT CLASSIFIED
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17131131
• MDR Text Key: 317468809
• Report Number: 3006948883-2023-00045
• Device Sequence Number: 1
• Product Code: GTY
• UDI-Device Identifier: 00382902560401
• UDI-Public: 00382902560401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122718
• 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: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 256040
• Device Catalogue Number: 256040
• Device Lot Number: 3012042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• 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