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 Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

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

Nit was reported while testing for sars cov-2 a false positive result was obtained.A repeat test was performed using a pcr test method and the result was negative.The customer stated the patient tested was symptomatic.Tthere was no indication that results were reported out or any report of patient impact.Eua (b)(4).

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/11/2020.H.6.Investigation: 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).The batch history records were reviewed and no discrepancies were noted.Functional analysis of retention materials met acceptance criteria.Returned products were received, however the material has passed expiration date and will not be tested.Bd makes no claims on expired products and stability studies have shown the use of expired materials may affect the sensitivity of the assay.Quality was unable to duplicate the customers reported failure mode.Complaint trending review reveals a trend in customer complaints related to false positive results, when using bd sars-cov-2 reagents for bd veritor¿ system.Although the investigation was not confirmed, based on the complaint trend, a corrective and preventive action (capa) was initiated (1878253) to determine root cause(s).Bd point of care will continue to closely monitor for trends associated with false positive or discrepant results when using the kit bd veritor for rapid detection of sars-cov-2.There was no corrective action taken at this time.

Event Description

Nit was reported while testing for sars cov-2 a false positive result was obtained.A repeat test was performed using a pcr test method and the result was negative.The customer stated the patient tested was symptomatic.Tthere was no indication that results were reported out or any report of patient impact.Eua(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: 11084634
• MDR Text Key: 224869562
• Report Number: 3006948883-2020-01051
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/10/2021
• Device Catalogue Number: 256082
• Device Lot Number: 0240155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1