MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU KIT GRP A STREP 30 TEST VERITOR; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

Catalog Number 256040

Device Problem False Positive Result (1227)

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

Event Date 11/03/2023

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 false positive results were obtained.Customer is sending swabs for culture and the cultures came back negative.No patient impact reported.

Manufacturer Narrative

The following fields have been updated with corrected and/or additional information: d10: device available for eval? yes.Returned to manufacturer on 20-nov-2023.H6: investigation summary: this statement is to summarize the investigation results regarding a complaint that alleges false positive results when using kit grp a strep 30 test veritor (material # 256040), batch numbers 3040598.Per customer, they were seeing an increase in positive strep a results from patients that do not present typical clinical symptoms.Customer was sending swabs for culture, and they came back as negative.They used other lot numbers and received acceptable results.Bd quality performs a systematic approach to investigate all false positive 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.Functional testing was performed on the devices returned by the customer, and the assay had typical intended results.No relevant issues were identified.The customer also provided the photograph of veritor analyzer; however, the reported issue could not be identified based on the photographs.The reported issue was unable to be confirmed based on the investigation.The root cause could not be determined.Currently no adverse trend for false positive was identified.H3 other text : see h.10.

Event Description

It was reported that while using kit grp a strep 30 test veritor false positive results were obtained.Customer is sending swabs for culture and the cultures came back negative.No patient impact reported.

• Brand Name: KIT GRP A STREP 30 TEST VERITOR
• Type of Device: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18194970
• MDR Text Key: 328990616
• Report Number: 3014704491-2023-00752
• Device Sequence Number: 1
• Product Code: GTY
• UDI-Device Identifier: 00382902560401
• UDI-Public: (01)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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

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 Catalogue Number: 256040
• Device Lot Number: 3040598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2023
• 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