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

Model Number 256042

Device Problem False Positive Result (1227)

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

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while testing with bd veritor¿ system for rapid detection of rsv - laboratory kit false positive results were obtained.Testing was repeated and result was negative.There was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: we observe many false positive results with lot number 128221 of bd's rsv antigen test.We obtain a line at the control and test line but with a wipe through.Is read as positive by reader but looks different than normal.When we repeat sample this atypical binding is gone.

Event Description

It was reported that while testing with bd veritor¿ system for rapid detection of rsv - laboratory kit false positive results were obtained.Testing was repeated and result was negative.There was no report of patient impact.The following information was provided by the initial reporter, translated from dutch to english: we observe many false positive results with lot number 128221 of bd's rsv antigen test.We obtain a line at the control and test line but with a wipe through.Is read as positive by reader but looks different than normal.When we repeat sample this atypical binding is gone.

Manufacturer Narrative

H6: investigation summary this statement is to summarize the investigation results regarding your complaint that alleges false positive when using kit rsv 30 test hospital veritor (material # 256042), batch number 0128221.Bd quality performs a systematic approach to investigate false positive 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.A photograph was returned and showed kit rsv 30 test hospital veritor's test results and unable to confirm of false positive.The reported issue was unable to be confirmed.The root cause could not be identified.No trend against false positive was identified.Currently no adverse trend for false positive was identified.H3 other text : see h10.

• Brand Name: BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - LABORATORY KIT
• Type of Device: ANTIGEN, CF (INCLUDING CF CONTROLS), 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14077321
• MDR Text Key: 289093122
• Report Number: 3006948883-2022-00110
• Device Sequence Number: 1
• Product Code: GQG
• UDI-Device Identifier: 00382902560425
• UDI-Public: 00382902560425
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K133140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

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 Expiration Date: 01/14/2023
• Device Model Number: 256042
• Device Catalogue Number: 256042
• Device Lot Number: 0128221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 04/18/2022
• Supplement Dates FDA Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2020
• 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