MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD RAPID DETECTION OF SARS-COV-2 VERITOR¿; CORONAVIRUS ANTIGEN DETECTION SYSTEM

Catalog Number 256082

Device Problem Non Reproducible Results (4029)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd rapid detection of sars-cov-2 veritor¿ assay discrepant results were obtained.The patient tested negative using the bd rapid detection of sars-cov-2 veritor¿ assay and subsequently tested positive for sars-cov-2 when using the binax now assay and one other unknown rapid test.No confirmatory testing was performed.No patient impact occurred as a result of the discrepant results.Eua (b)(4).

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).H3 other text : see h10.

Event Description

It was reported that while using the bd rapid detection of sars-cov-2 veritor¿ assay discrepant results were obtained.The patient tested negative using the bd rapid detection of sars-cov-2 veritor¿ assay and subsequently tested positive for sars-cov-2 when using the binax now assay and one other unknown rapid test.No confirmatory testing was performed.No patient impact occurred as a result of the discrepant results.Eua (b)(4).

Manufacturer Narrative

H.6.Investigation summary: this statement summarizes the investigation results regarding a complaint that alleges discrepant result when using bd veritor¿ sars-cov-2 veritor kit (material#: 256082), batch number 3199773.The customer reported that they tested positive twice with different at home tests, however received a negative result when using the veritor kit.Bd quality performs a systematic approach to investigate all complaints.This approach involves review of manufacturing batch history records, visual inspection of retention samples, and visual inspection 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 photos or samples were received; therefore, return sample analysis could not be performed.The reported issue was unable to be confirmed.A trend analysis for discrepant result was conducted, no adverse trend was identified.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.H3 other text : see h.10.

• Brand Name: BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
• 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: 18416508
• MDR Text Key: 331587854
• Report Number: 3006948883-2023-00139
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00382902560661
• UDI-Public: (01)00382902560661
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H 10
• 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: 05/08/2024

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 Expiration Date: 04/02/2024
• Device Catalogue Number: 256082
• Device Lot Number: 3199773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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