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 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

G5: pma/510(k)# - (b)(4).H3.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 while using the bd veritor ¿ sars-cov-2 & flu a+b the customer obtained a discrepant result.The analyzer provided an invalid result, but the customer visually read the test device and concluded that the results were inaccurate due to visible positive lines being present on the device.There was no report of patient impact.(b)(4).

Event Description

It was reported while using the bd veritor ¿ sars-cov-2 & flu a+b the customer obtained a discrepant result.The analyzer provided an invalid result, but the customer visually read the test device and concluded that the results were inaccurate due to visible positive lines being present on the device.There was no report of patient impact.Eua(b)(4).

Manufacturer Narrative

H.6.Investigation summary: this summarizes the investigation results regarding a complaint that alleges invalid result (multiple lines present on test cartridge) when using rapid detection of sars-cov-2 & flu a+b kit (material #256088 ), batch number 3004372.The customer reported inaccurate test result as they observed multiple positive test lines on the test cartridge.The customer informed that her provider advised her not to insert the cartridge into the analyzer if they observe multiple lines.Bd quality performs a systematic approach to investigate all 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.The results were acceptable, and no relevant issues were found.No physical samples were received; therefore, no return sample analysis could be performed, however photographs were returned and showed the test cartridge with multiple lines.Multiple lines may show up on non-specific binding areas on the cartridge and that all results should be always read by the analyzer.This complaint could not be confirmed.A trend analysis for this issue was conducted, no adverse trend was identified.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.

• 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: 18185979
• MDR Text Key: 328709179
• Report Number: 3014704491-2023-00749
• 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: 12/14/2023

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: 04/14/2024
• Device Catalogue Number: 256088
• Device Lot Number: 3004372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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