MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD VERITOR ¿ SARS-COV-2 & FLU A+B; DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS

Catalog Number 256088

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

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

Event Date 02/13/2024

Event Type  malfunction  

Event Description

It was reported while using the bd veritor ¿ sars-cov-2 & flu a+b the user received discrepant results for a symptomatic patient.The initial result was covid positive while upon repeat the result was flu a positive.No health impact or consequence reported.

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

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 and flu a+b ass (material#: 256088), batch number 3216617.The customer reported that they were receiving covid positive, flu a negative and flu b negative when testing a symptomatic patient.They then retested the same sample in a different device and received a flu a positive result.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 return samples were received; therefore, no return sample analysis could be performed.However, a photograph was returned and showed one device with covid positive, flu a negative, flu b negative result and the other device with flu a positive, flu b negative and covid negative results.This complaint was confirmed based on the photographic evidence.The root cause could not be determined.A trend analysis for discrepant result was conducted, no adverse trend was identified.There were no corrective actions taken at this time.

Event Description

It was reported while using the bd veritor ¿ sars-cov-2 & flu a+b the user received discrepant results for a symptomatic patient.The initial result was covid positive while upon repeat the result was flu a positive.No health impact or consequence reported.

• Brand Name: BD VERITOR ¿ SARS-COV-2 & FLU A+B
• Type of Device: DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS
• 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: 18856050
• MDR Text Key: 337777537
• Report Number: 3006948883-2024-00035
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2024

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: 3216617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 06/27/2024
• Supplement Dates FDA Received: 07/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2023
• 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