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

Catalog Number 256045

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

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

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

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

Report 2 of 2 it was reported that while using bd veritor system for rapid detection of flu a+b clia-waved kit, there was a false positive result of an employee.Employee was isolated and retested the next morning.Employee came out negative.The following information was provided by the initial reporter: "on (b)(6) 2023, customer obtained 2 pos result for symptomatic employees using 256045 lot # 2356753; these employees were isolated for yesterday; customer ran out of that reagents lot, and these two employees were re-tested the next morning (today) with a new lot (2333594) - both came out negative.Customer stated that no erroneous results or patient impact was reported.".

Event Description

Report 2 of 2 it was reported that while using bd veritor¿ system for rapid detection of flu a+b clia-waved kit, there was a false positive result of an employee.Employee was isolated and retested the next morning.Employee came out negative.The following information was provided by the initial reporter: "on 08/21/23, customer obtained 2 pos result for symptomatic employees using 256045 lot # 2356753; these employees were isolated for yesterday; customer ran out of that reagents lot, and these two employees were re-tested the next morning (today) with a new lot (2333594) - both came out negative.Customer stated that no erroneous results or patient impact was reported.".

Manufacturer Narrative

This statement is to summarize the investigation results regarding a complaint that alleges discrepant results between the lot numbers when using kit rapid detection of kit flu a+b 30 test physician veritor (material # 256045), batch number 2356753.According to the report, the customer obtained 2 positive results for symptomatic employees using lot # 2356753.These employees were isolated on the same day and the customer ran out of that reagent lot, so the two employees were re-tested the next day morning with a new lot (2333594) - both came out negative.During trouble shooting, the bd representative suggested a possibility of the previous kit (2356753) contamination by workflow errors, emphasized the necessity of changing gloves after each patient, disinfect the working area, and not touch the kit reagents with the gloves that were used for the previous patient.Customer agreed and no issues with the second lot were observed.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.Bhr (batch history review) analysis and retain sample testing were performed on the batch number provided.The results were acceptable, and no relevant issues were found.No return samples were received; therefore, no return sample analysis could be performed.This complaint was unable to be confirmed.Currently no adverse trend identified for the reported issue.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17627051
• MDR Text Key: 322068644
• Report Number: 3006948883-2023-00090
• 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: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256045
• Device Lot Number: 2356753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2022
• 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