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 Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported while testing for sars cov-2 a false positive result was obtained.A repeat test was performed using either the pcr method or the cepheid genexpert method.Upon repeat, the result was negative.The customer stated the patient tested was asymptomatic.This test is not intended for use on asymptomatic patients and was therefore used off label.There was no indication that results were reported out or any report of patient impact.Eua (b)(4).

Manufacturer Narrative

Eua#: (b)(4) investigation summary: bd has received several customer complaints for false positive results, when using bd sars-cov-2 reagents for bd veritor¿ system.The current investigation concerns multiple lots of bd sars-cov-2 reagents for bd veritor¿ system.Bd takes a systematic approach to investigating false positive complaints that are received.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples if applicable.Retain samples were tested for batch #: 0275996.The defect could not be replicated and therefore the complaint could not be confirmed.A device history review was conducted for lot number 0275996.The investigation did not find a root cause for the false positive results that were observed.It is recommended that each customer review their workflow carefully to ensure that the package insert is being followed as written.The root cause is under investigation and will be documented in our quality system.Bd cannot confirm the complaint based on the investigation that was performed.A corrective and preventive action (capa#1878253) is already initiated to investigate the root cause and some mitigation actions are already being addressed.

Event Description

It was reported while testing for sars cov-2 a false positive result was obtained.A repeat test was performed using either the pcr method or the cepheid genexpert method.Upon repeat, the result was negative.The customer stated the patient tested was asymptomatic.This test is not intended for use on asymptomatic patients and was therefore used off label.There was no indication that results were reported out or any report of patient impact.(b)(4).

• 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
• MDR Report Key: 11141123
• MDR Text Key: 227834243
• Report Number: 3006948883-2021-00035
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/08/2021

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: 03/15/2021
• Device Catalogue Number: 256082
• Device Lot Number: 0275996
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 08/08/2021
• Supplement Dates FDA Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1