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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU KIT GRP A STREP 30 TEST VERITOR; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. Back to Search Results
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.
 
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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 Key18194970
MDR Text Key328990616
Report Number3014704491-2023-00752
Device Sequence Number1
Product Code GTY
UDI-Device Identifier00382902560401
UDI-Public(01)00382902560401
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122718
Number of Events Reported1
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 Number256040
Device Lot Number3040598
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 Received11/22/2023
Supplement Dates Manufacturer Received12/22/2023
Supplement Dates FDA Received01/18/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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