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 Inaccurate Information (4051)

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

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

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 the customer discovered a discrepancy between the package insert and the quick start guide in the kit grp a strep 30 test veritor.The package insert stated that specimens could be stored for 48 hrs hours at 2-8 c, and the quick start guide indicates 72 hours at 2-8 c.There was no report of patient impact.The following information was provided by the initial reporter: customer wants to confirm if the specimen storage was 48 hrs (as stated in pi) or 72 hours (as stated in the quick reference guide) as they found discrepant information for the same product.

Event Description

It was reported that the customer discovered a discrepancy between the package insert and the quick start guide in the kit grp a strep 30 test veritor.The package insert stated that specimens could be stored for 48 hrs hours at 2-8 c, and the quick start guide indicates 72 hours at 2-8 c.There was no report of patient impact.The following information was provided by the initial reporter: customer wants to confirm if the specimen storage was 48 hrs (as stated in pi) or 72 hours (as stated in the quick reference guide) as they found discrepant information for the same product.

Manufacturer Narrative

H.6 investigation summary this statement is to summarize the investigation results regarding a complaint that alleges discrepant specimen storage time on the package insert (pi) and quick reference guide (qrg) when using bd grp a strep 30 test veritor kit (material # 256040), batch number 1295326.Bd quality performs a systematic approach to investigate labelling / packaging issue 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 provided information, it was understood that the customer reported different specimen storage time stated on the pi and qrg in the kit and they wanted to confirm if the specimen storage was 48 hours (as stated in pi) or 72 hours (as stated in the qrg) as they found discrepant information for the same product.Bhr review and retain sample analysis was not performed because the reported issue alleging the discrepant information not with product malfunction.Further investigation was done by bd research & development (r & d) on this issue, and it was confirmed that the insert has a different time specimen storage of 48hours vs qrg of 72hour.Bd will update the pi to 72hours to align with the qrg per baltqp2106, labeling development request (ldr).The specimen storage time change to 48hours was an error and the pi will be reversed to say 72 hours.This complaint was confirmed.The root cause was traced to labelling.Currently, there are no adverse trends identified for labelling / packaging issue.Bd quality will continue to monitor for trends.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15953207
• MDR Text Key: 305830595
• Report Number: 3006948883-2022-00196
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• 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: 1295326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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