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 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, 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.Confirmatory testing was performed using pcr test method and the result was negative.There was no report of patient impact.Customer has stated no additional details will be provided.Eua # (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 0279956.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.No investigations nor retain product testing was performed on batch number 0279956 as it was not a valid batch number associated with the kit rapid detection of sars-cov-2 veritor (material # 256082).A trend was identified for false positive results.Based on the trend, capa#1878253 was initiated.Bd quality will continue to monitor for trends.There were no corrective actions taken at this time.See h.10.

Event Description

It was reported while testing for sars-cov-2 a false positive result was obtained.Confirmatory testing was performed using pcr test method and the result was negative.There was no report of patient impact.Customer has stated no additional details will be provided.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: 11016024
• MDR Text Key: 224409222
• Report Number: 1119779-2020-01216
• 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: 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256082
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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