MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR SYSTEM FOR RAPID DETECTION OF RSV; ANTIGEN, CF , RESPIRATORY SYNCYTIAL VIRUS

Model Number 256042

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

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

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 bd veritor system for rapid detection of rsv (b)(6)results were obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "discrepancy on results.Customer is getting discrepancy results on rsv 256042 lot: 9227487 exp: 3/6/2022".

Event Description

It was reported that while using bd veritor system for rapid detection of rsv 3 false positive results were obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "discrepancy on results.Customer is getting discrepancy results on rsv 256042 lot: 9227487 exp: 3/6/2022".

Manufacturer Narrative

H6: investigation summary this statement summarizes the investigation results regarding the complaint that alleges getting discrepant results (positive result is negative when repeated) when using kit rsv 30 test hospital veritor (material # 256042), batch number 9227487.Bd quality performs a systematic approach to investigate discrepant results complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation and testing were performed on the batch number provided and no relevant issue was found.The complaint was unable to be confirmed via the retain samples.The root cause could not be identified.A trend analysis discrepant results was conducted, no adverse trend was identified.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.H3 other text : see h10.

• Brand Name: BD VERITOR SYSTEM FOR RAPID DETECTION OF RSV
• Type of Device: ANTIGEN, CF , RESPIRATORY SYNCYTIAL VIRUS
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12530516
• MDR Text Key: 273375247
• Report Number: 3006948883-2021-00947
• Device Sequence Number: 1
• Product Code: GQG
• UDI-Device Identifier: 00382902560425
• UDI-Public: 00382902560425
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133140
• 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: 12/23/2021

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 Model Number: 256042
• Device Catalogue Number: 256042
• Device Lot Number: 9227487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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