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 False Positive Result (1227)

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

Event Date 07/01/2023

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 3 of 15: it was reported that while using bd veritor¿ system for rapid detection of flu a+b clia-waved kit, there was a flu a false positive of a patient sample.No patient impact reported.The following information was provided by the initial reporter: "customer is reporting flu a false positives for product 256045 how many discrepant results are being reported? about 15 different patients.All for flu a.Customer states that they had three false positives for lot no.3096419 from today but has been an on-going issue since july.Were the kit qc swabs tested and if so, did they pass? yes, qc passed.How was the specimen collected? does it follow correction instructions as outlined in the ifu (confirm the assay and collection method in ifu)? customer is the lab manager.Customer states she reviewed the ifu with the staff and confirmed test collection and testing is being performed properly.What type of swab was used to collect the specimen? the swab that comes with the kit.Was any transport media used? (this would be outside pi claims) no.Was patient symptomatic or asymptomatic? all patients are symptomatic.How was it determined to be discrepant? was another method used for comparison? customer confirms result via pcr testing.If pcr was alternate method used to confirm result, what pcr test was used? cepheid genexpert.Was the sample repeated on the veritor? yes, and on different veritor plus analyzers.The result is still positive for flu a".

Manufacturer Narrative

H.6.Investigation summary: this statement is to summarize the investigation results regarding the complaint that alleges ¿false positive results¿ when using kit flu a+b 30 test physician veritor (material # (b)(4)), batch numbers 3096419.The customer reported receiving 15 flu a false positive results for 15 symptomatic patients.The results were confirmed via pcr testing.During trouble shooting, the customer stated that they followed the correct workflow.Qc were performed and passed.Bd quality performs a systematic approach to investigate false positive 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 numbers provided.The results were acceptable, and no relevant issues were found.No photos or physical samples were returned, as a result return sample analysis could not be performed.The reported issue was unable to be confirmed.The root cause could not be identified.Currently no adverse trend identified for the reported issue.Bd quality will continue to 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.H3 other text : see h.10.

Event Description

Report 3 of 15 it was reported that while using bd veritor¿ system for rapid detection of flu a+b clia-waved kit, there was a flu a false positive of a patient sample.No patient impact reported.The following information was provided by the initial reporter: "customer is reporting flu a false positives for product 256045 how many discrepant results are being reported? about 15 different patients.All for flu a.Customer states that they had three false positives for lot no.3096419 from today but has been an on-going issue since july.· were the kit qc swabs tested and if so, did they pass? yes, qc passed.· how was the specimen collected? does it follow correction instructions as outlined in the ifu (confirm the assay and collection method in ifu)? customer is the lab manager.Customer states she reviewed the ifu with the staff and confirmed test collection and testing is being performed properly.· what type of swab was used to collect the specimen? the swab that comes with the kit o was any transport media used? (this would be outside pi claims) no · was patient symptomatic or asymptomatic? all patients are symptomatic.· how was it determined to be discrepant? was another method used for comparison? customer confirms result via pcr testing.O if pcr was alternate method used to confirm result, what pcr test was used? cepheid genexpert · was the sample repeated on the veritor? yes, and on different veritor plus analyzers.The result is still positive for flu a.".

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18069299
• MDR Text Key: 327719729
• Report Number: 3014704491-2023-00701
• 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: 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: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256045
• Device Lot Number: 3096419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• 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