MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT; SEE H.10

Model Number 256045

Device Problem False Positive Result (1227)

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

Event Date 12/07/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Common device name: antigens, cf (including cf control), influenza virus a, b, and c.Initial reporter facility name: (b)(4).

Event Description

It was reported that while using the bd veritor¿ system for rapid detection of flu a+b clia-waved kit that there was false positives.The following information was provided by the initial reporter: customer states fp result obtained.

Manufacturer Narrative

Updated lot number.H.6 investigation summary this statement is to summarize the investigation results regarding the complaint that alleges ¿false positive result¿ when using kit flu a+b 30 test physician veritor (material # 256045), batch number 0010283.It was reported that the customer received positive flu a result on a symptomatic patient with veritor.Then the patient was transported to hospital and obtained a negative flu a result with cepheid 4plex plus on the same day.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.An investigation was performed on the batch number provided.The batch history record (bhr) review results are acceptable, and no relevant issues were identified.Returned products were tested and all devices tested had typical intended results.No issues were identified.The complaint was unable to be confirmed.The root cause could not be identified.There are no current trends against false positive.Bd quality will continue to closely monitor for trends.There were no corrective actions taken at this time.

Event Description

It was reported that while using the bd veritor¿ system for rapid detection of flu a+b clia-waved kit that there was false positives.The following information was provided by the initial reporter: customer states fp result obtained.

• Brand Name: BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
• Type of Device: SEE H.10
• 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: 16096187
• MDR Text Key: 306830187
• Report Number: 3006948883-2022-00200
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/29/2022
• Device Model Number: 256045
• Device Catalogue Number: 256045
• Device Lot Number: 0010283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2020
• 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