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 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 veritor ¿ sars-cov-2 & flu a+b assay discrepant results were obtained.The patient tested negative using the bd veritor ¿ sars-cov-2 & flu a+b 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 203152.

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 203152 h3 other text : see h10.

• 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: 18411331
• MDR Text Key: 331728263
• Report Number: 3006948883-2023-00140
• 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: SEE H 10
• 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
• Report Date: 12/08/2023

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: 04/16/2024
• Device Catalogue Number: 256088
• Device Lot Number: 3009036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• 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