MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) 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 12/03/2020

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

It was reported while testing for sars cov-2 a false positive result was obtained.The sample was repeated on the veritor and pcr test method and 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.The results were reported to the state health department.There was no report of patient impact.(b)(4).

Manufacturer Narrative

H.6.Investigation: this statement summarizes the investigation results regarding the complaint that alleges false positive results when using kit rapid detection of sars-cov-2 veritor (material#: 256082), batch number: 0245289.Bd quality performs a systematic approach to investigate false positive complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.Testing were performed on the batch number provided and no issue was found.The complaint was unable to be confirmed via the retained samples.A photo was provided.The complaint issue could not be confirmed via the photo.The root cause could not be identified.A trend was identified for false positive results.Based on the trend, capa#: 1878253 was initiated.There were no corrective actions taken at this time.

Event Description

It was reported while testing for sars cov-2 a false positive result was obtained.The sample was repeated on the veritor and pcr test method and 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.The results were reported to the state health department.There was no 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): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11089564
• MDR Text Key: 225565059
• Report Number: 1119779-2020-01278
• Device Sequence Number: 1
• Product Code: QKP
• 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: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/22/2020
• Device Catalogue Number: 256082
• Device Lot Number: 0245289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• 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