MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. KIT GRP A STREP 30 TEST VERITOR; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Model Number 256040

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

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

Event Date 07/30/2021

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.

Event Description

It was reported while testing with kit grp a strep 30 test veritor results were different when using 2 different veritor analyzers.There was no report of confirmatory testing or patient impact.The following information was provided by the initial reporter: it was reported that customer called to report that their veritor group a strep kit is giving out inconsistent results.

Manufacturer Narrative

H6: investigation summary: this statement is to summarize the investigation results regarding the complaints that alleges false positive or discrepant results when using bd kit grp a strep 30 test veritor (mn# 256040), batch number 0016857.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.No trend against false positive or discrepant results was identified.The root cause could not be identified.Bd quality will continue to closely monitor for trends.

Event Description

It was reported while testing with kit grp a strep 30 test veritor results were different when using 2 different veritor analyzers.There was no report of confirmatory testing or patient impact.The following information was provided by the initial reporter: it was reported that customer called to report that their veritor group a strep kit is giving out inconsistent results.

• Brand Name: KIT GRP A STREP 30 TEST VERITOR
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12359966
• MDR Text Key: 267882144
• Report Number: 3006948883-2021-00893
• 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: 12/20/2021

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: 10/29/2022
• Device Model Number: 256040
• Device Catalogue Number: 256040
• Device Lot Number: 0016857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 12/20/2021
• Supplement Dates FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• 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