MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD VERITOR SYSTEM FOR RAPID DETECTION OF GROUP A STREP; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Catalog Number 256040

Device Problem False Negative Result (1225)

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

Event Date 09/22/2023

Event Type  malfunction  

Event Description

It was reported that during use with bd veritor system for rapid detection of group a strep a false negative result was obtained.The cartridge was inserted into a second analyzer and the result was positive.There was no patient impact.The following information was provided by the initial reporter: customer determines if they are going to reinsert the cartridge into another analyzer if there are visually 2 lines on the cartridge and the analyzer shows negative.Not inserting into a second analyzer if it's positive by the analyzer customer stated that there was no patient impact and that it is up to the physician to decide treatment based on symptoms and test result.

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Manufacturer Narrative

H.6.Investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges false negative results when using kit grp a strep 30 test veritor (material # 256040), batch number unknown.The customer reported that when performing the test, 2 lines were seen on the cartridge, but the analyzer read the test as negative.The customer removed the cartridge and placed it in another analyzer and the result was positive.Culture was the confirmatory test for negative results.The customer stated that there was no patient impact, and it was up to the physician to decide the treatment based on the symptoms and test result.Bd representative advised the customer that visual read should not be performed for this test and instructed not to reinsert the same cartridge into the analyzer.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.Batch history record (bhr) review and retain sample testing could not be performed because the batch number was not provided.No photos or physical samples were received; therefore, no return sample analysis could be performed.This complaint was unable to be confirmed.Currently no adverse trend for false negative was identified.Bd quality will continue to closely monitor for trends.

Event Description

It was reported that during use with bd veritor system for rapid detection of group a strep a false negative result was obtained.The cartridge was inserted into a second analyzer and the result was positive.There was no patient impact.The following information was provided by the initial reporter: customer determines if they are going to reinsert the cartridge into another analyzer if there are visually 2 lines on the cartridge and the analyzer shows negative.Not inserting into a second analyzer if it's positive by the analyzer customer stated that there was no patient impact and that it is up to the physician to decide treatment based on symptoms and test result.

• Brand Name: BD VERITOR SYSTEM FOR RAPID DETECTION OF GROUP A STREP
• Type of Device: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17935941
• MDR Text Key: 326144802
• Report Number: 1119779-2023-01119
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• 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