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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. KIT GRP A STREP 30 TEST VERITOR; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 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 10/19/2023
Event Type  malfunction  
Event Description
It was reported that while using the kit grp a strep 30 test veritor that there was a false positive.The following information was provided by the initial reporter: customer reports they have detected and increase on positive results for the strep kit that does not match with patient symptoms.
 
Manufacturer Narrative
D4.Medical device lot #: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture 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.
 
Event Description
It was reported that while using the kit grp a strep 30 test veritor that there was a false positive.The following information was provided by the initial reporter: customer reports they have detected and increase on positive results for the strep kit that does not match with patient symptoms.
 
Manufacturer Narrative
H.6 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 number unknown.The customer reported that they have detected an increase in positive results for the strep kit that do not match with patient symptoms.They disposed of the kit box, so they were unable to provide a lot number.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 could not be performed as no batch number was provided.No photos or physical samples were received; therefore, return sample analysis could not be performed.The reported issue was unable to be confirmed.The root cause could not be identified.Currently no adverse trend for false positive was identified.Bd quality will continue to closely monitor for trends.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.
 
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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 
Manufacturer (Section G)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
CH  
Manufacturer Contact
jo doyka
7 loveton circle
sparks, MD 21152
4103164000
MDR Report Key18219492
MDR Text Key329149962
Report Number3006948883-2023-00114
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,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/29/2024
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 NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/19/2023
Initial Date FDA Received11/28/2023
Supplement Dates Manufacturer Received11/21/2023
Supplement Dates FDA Received02/29/2024
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 Number1
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