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

Model Number 256040

Device Problem False Positive Result (1227)

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

Event Date 04/24/2023

Event Type  malfunction  

Event Description

It was reported that kit grp a strep 30 test veritor results are negative however after some time they turn positive.The following information was provided by the initial reporter: the customer reported that after following the procedure of testing for strep throat, the result is negative after 15-20 minutes from using the kit but noticed that if they forget the kit and didn¿t dispose it, it turns positive after around 1 hour.He indicates it happened a few times and he¿s questioning the accuracy of the result.Should he use the rapid negative within 20 minutes or the late positive after 1 hour or more.This is critical regarding prescribing antibiotic or not.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

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 3017017.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.Based on the available information understood that customer got negative result but noticed that they turn positive after around 1 hour.The test was never designed to read visually, in order to obtain accurate results, the group a strep result must be read using the bd veritor plus analyzer, after allowing the test to develop for five (5) minutes.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 return samples were received; therefore, no return sample analysis could be performed.Customer was received a valid test (negative result) with analyzer.The test was designed 5 minutes to develop the assay and analyze in the analyzer.The customer was tried to read the result once again using the same cartridge after the 60 minutes post initial test was performed, which was resulted in the false positive.The root cause was identified as cause traced to user.If customer is in symptomatic and need to verify the result, they could perform another test or can be perform a pcr test to confirm the results.The reported issue was unable to 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.

Event Description

It was reported that kit grp a strep 30 test veritor results are negative however after some time they turn positive.The following information was provided by the initial reporter: the customer reported that after following the procedure of testing for strep throat, the result is negative after 15-20 minutes from using the kit but noticed that if they forget the kit and didn¿t dispose it, it turns positive after around 1 hour.He indicates it happened a few times and he¿s questioning the accuracy of the result.Should he use the rapid negative within 20 minutes or the late positive after 1 hour or more.This is critical regarding prescribing antibiotic or not.

• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16939044
• MDR Text Key: 315568274
• Report Number: 3014704491-2023-00197
• Device Sequence Number: 1
• Product Code: GTY
• UDI-Device Identifier: 00382902560401
• UDI-Public: 00382902560401
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K122718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

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 Model Number: 256040
• Device Catalogue Number: 256040
• Device Lot Number: 3017017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 06/09/2023
• Supplement Dates FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1