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 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

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 kit grp a strep 30 test veritor 4 false negative results were obtained by the laboratory personnel.The test was not repeated and confirmatory testing was not performed.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that possible 4 false negative results.

Manufacturer Narrative

H6: investigation summary: this statement summarizes the investigation results regarding your complaints that alleges false negative or discrepant results when using kit grp a strep 30 test veritor (material # 256040), batch number 0064045.Bd quality performs a systematic approach to investigate false negative complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples if applicable.Investigation and testing were performed on the batch number provided.The complaint was unable to be confirmed.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.H3 other text : see h10.

Event Description

It was reported that while using kit grp a strep 30 test veritor 4 false negative results were obtained by the laboratory personnel.The test was not repeated and confirmatory testing was not performed.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that possible 4 false negative 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
• MDR Report Key: 12005365
• MDR Text Key: 256540774
• Report Number: 3006948883-2021-00688
• Device Sequence Number: 1
• Product Code: GTY
• UDI-Device Identifier: 00382902560401
• UDI-Public: 00382902560401
• Combination Product (y/n): N
• PMA/PMN Number: K122718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/02/2022
• Device Model Number: 256040
• Device Catalogue Number: 256040
• Device Lot Number: 0064045
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1