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 11/27/2020

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).Medical device lot #: 0262358 was reported, however, this is not a lot# manufactured for this product #.

Event Description

It was reported while testing for sars cov-2 a false positive result was obtained.A repeat test was performed using pcr and the result was negative.The customer stated they are testing asymptomatic patients.This test is not intended for use on asymptomatic patients and was therefore used off label.The customer stated results were not reported out so there was no report of patient impact.Eua#: (b)(4).

Manufacturer Narrative

H6: investigation: this statement is to summarize the investigation results regarding the complaint that alleges contamination/foreign material issue when using kit rapid detection of sars-cov-2 veritor (material # 256082) batch number 0262358.Bd quality performs a systematic approach to investigate contamination/foreign material complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation and testing were performed on the batch number provided and no issue was found.The complaint was unable to be confirmed via the retain samples.Photos were provided.The complaint issue was confirmed via the photos.The root cause was traced to the user since the entry description states "no contaminants were observed before using the kit".A trend analysis for contamination/foreign material issues was conducted, no adverse trend was identified.No corrective actions were taken at this time.

Event Description

It was reported while testing for sars cov-2 a false positive result was obtained.A repeat test was performed using pcr and the result was negative.The customer stated they are testing asymptomatic patients.This test is not intended for use on asymptomatic patients and was therefore used off label.The customer stated results were not reported out so there was no report of patient impact.Eua#: 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: 11023390
• MDR Text Key: 223181196
• Report Number: 1119779-2020-01241
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 256082
• Device Lot Number: 0262358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 11/29/2021
• 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