MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) KIT GRP A STREP 30 TEST VERITOR; 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 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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, there was one false negative result.No patient impact reported.The following information was provided by the initial reporter: "ver 256040_3044705 - false negatives.Customer reports that the cartridge looks positive, the analyzer says the result is negative, and the culture comes back positive.".

Manufacturer Narrative

H.6.Investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges false negatives when using kit grp a strep 30 test veritor (material # 256040), batch numbers 3044705.The customer reported that the cartridge looked positive, but the analyzer interpreted the result as negative.Subsequently the culture test result came back as positive.During trouble shooting, the bd representative walked through the workflow with the customer and determined that they had not added reagent 1 before adding the swab to the reagent 2 tube.The customer was instructed to obtain the pi (product information document) and follow the correct workflow.Bd quality performs a systematic approach to investigate all 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 were performed on the batch number provided.The results were acceptable, and no relevant issues were identified.No samples were returned; as a result, return sample analysis could not be conducted.Currently no adverse trend for false negative was identified.This complaint was unable to be confirmed.H3 other text : see h.10.

Event Description

It was reported that while using kit grp a strep 30 test veritor, there was one false negative result.No patient impact reported.The following information was provided by the initial reporter: "ver 256040_3044705 - false negatives.Customer reports that the cartridge looks positive, the analyzer says the result is negative, and the culture comes back positive".

• Brand Name: KIT GRP A STREP 30 TEST VERITOR
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17624106
• MDR Text Key: 321956161
• Report Number: 1119779-2023-00942
• 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: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256040
• Device Lot Number: 3044705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• 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