MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 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 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.

• 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 Key: 18219492
• MDR Text Key: 329149962
• Report Number: 3006948883-2023-00114
• 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,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 Number: 256040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 11/21/2023
• Supplement Dates FDA Received: 02/29/2024
• 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 Number: 1