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 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

G.5.Eua number: eua (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 user visually interpreted the result and perceived the result as discrepant.The user saw one (1) line on the cartridge after inoculation, inserted the cartridge into the analyzer, which read it as positive, then removed the cartridge and reinserted it 1-2 minutes later, which was then read as negative by the analyzer.No health impact or consequence reported.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: 19078850
• MDR Text Key: 340687760
• Report Number: 3006948883-2024-00047
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

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 Catalogue Number: 256088
• Device Lot Number: 3240177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2023
• 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