MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR¿; SYSTEM FOR RAPID DETECTION OF GROUP A STREP; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Model Number 256040

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported while running correlation study on patient samples with bd veritor¿; system for rapid detection of group a strep 3 false positive results were obtained.Testing also performed with fisher sure-vue and obtained negative results.Confirmatory test was not performed.There was no report of patient impact.

Event Description

It was reported while running correlation study on patient samples with bd veritor¿; system for rapid detection of group a strep 3 false positive results were obtained.Testing also performed with fisher sure-vue and obtained negative results.Confirmatory test was not performed.There was no report of patient impact.

Manufacturer Narrative

H.6.Investigation: this statement is to summarize the investigation results regarding the complaint that alleges false positive or discrepant results when using kit kit grp a strep 30 test veritor (material # 256040), batch number 0198381.Bd quality performs a systematic approach to investigate false positive or 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.The reported issue was unable to be confirmed.The root cause could not be identified.Bd quality will continue to closely monitor for trends.H3 other text : see h.10.

• Brand Name: BD VERITOR¿; SYSTEM FOR RAPID DETECTION OF GROUP A STREP
• Type of Device: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11335003
• MDR Text Key: 247505607
• Report Number: 3006948883-2021-00229
• Device Sequence Number: 1
• Product Code: GTY
• UDI-Device Identifier: 00382902560401
• UDI-Public: 00382902560401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122718
• 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: 11/22/2021

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 Expiration Date: 11/19/2022
• Device Model Number: 256040
• Device Catalogue Number: 256040
• Device Lot Number: 0198381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2020
• 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