MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR ¿ SARS-COV-2 & FLU A+B; CORONAVIRUS ANTIGEN DETECTION SYSTEM

Catalog Number 256088

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/12/2023

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.Eua#(b)(4).

Event Description

It was reported while using the bd veritor ¿ sars-cov-2 & flu a+b the customer obtained an error 26 on their test device and decided to report out the result as positive.There was no report of patient impact, the user waited for pcr results to determine treatment.Bd followed up multiple times with the customer to obtain the pcr results, but the customer has not responded to follow-up attempts.Eua#(b)(4).

Manufacturer Narrative

The following fields have been updated with additional information: d.9.Device available for evaluation: yes.D.9.Returned to manufacturer on: 07-nov-2023.H.6.Investigation summary: this statement is to summarize the investigation results regarding a complaint that involved bd veritor¿ sars-cov-2 and flu a+b (material #: 256088), batch number: 2348238.The customer reported receiving an erroneous result for 1 patient sample.According to them, the patient was not treated based on the erroneous results, and they were instructed to await the pcr test result.Bd quality performs a systematic approach to investigate discrepant results 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, results were acceptable, and no relevant issues were found.The tests were performed on the returned products.All the devices tested had typical intended results.No discrepant results or issues were identified.This complaint was unable to be confirmed.The root cause could not be determined.Currently no adverse trend for discrepant results 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 while using the bd veritor ¿ sars-cov-2 & flu a+b the customer obtained an error 26 on their test device and decided to report out the result as positive.There was no report of patient impact, the user waited for pcr results to determine treatment.Bd followed up multiple times with the customer to obtain the pcr results, but the customer has not responded to follow-up attempts.Eua (b)(4).

• Brand Name: BD VERITOR ¿ SARS-COV-2 & FLU A+B
• Type of Device: CORONAVIRUS ANTIGEN DETECTION SYSTEM
• 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: 18218680
• MDR Text Key: 329143322
• Report Number: 3006948883-2023-00113
• Device Sequence Number: 1
• Product Code: QMN
• UDI-Device Identifier: 00382902580881
• UDI-Public: (01)00382902580881
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• 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: 12/09/2023

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 Expiration Date: 03/22/2024
• Device Catalogue Number: 256088
• Device Lot Number: 2348238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2022
• 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