MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD FOCAL POINT"120V / 15 FOV (REFURBISHED); SEE H.10

Catalog Number 490398

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd focal point"120v / 15 fov (refurbished) that there was a false negatives.The following information was provided by the initial reporter: customer reports that on 2/14 there was a variance where low grade cells were not found in the areas designated by the focalpoint but were found outside those areas by a qc full re-screen.Customer reports this was the only false negative slide determined for month of february.No erroneous reports were sent out.Results were not confirmed by biopsy.Reporting for documentation.No follow up needed.Fp - (b)(4) fp did not pick up low grade.

Manufacturer Narrative

Common device name: processor, cervical cytology slide, automated.Initial reporter e-mail: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary this complaint alleges false negative result on the focalpoint instrument (p/n 490398, s/n (b)(6)).The customer called in to report that during regular qc screening they found low grade cells on the slide outside of the field of view (fov's).The initial report was corrected before results were sent to the patient.Per the focalpoint gs false negative test work instruction with 1 false negative reported, the machine is operating within claims.This work instruction provides methodology for determining whether the system is operating within the product insert claims based on clinical trial data.Samples were not received by quality for investigation and thus, returned material investigation could not occur.Review of device history record is not required because this complaint does not allege an early life failure or failure at installation and has changed configuration since release from manufacturing due to service repairs/pms.Service history review was performed for the instrument and no additional work orders were observed for the complaint failure mode reported.The root cause is unknown at this time.This complaint is unconfirmed as the sample was not returned for investigation.Bd will continue to closely monitor trends associated with this complaint.Complaint history for results was reviewed for the month of february.The upper control limit was not breached, and trends were not identified associated with this defect.No new trends, risks, or hazards were identified as a result of this complaint.The issue in this complaint does not require the initiation of a capa.This complaint will be included in the periodic trend review.

Event Description

It was reported that while using the bd focal point"120v / 15 fov (refurbished) that there was a false negatives.The following information was provided by the initial reporter: customer reports that on 2/14 there was a variance where low grade cells were not found in the areas designated by the focalpoint but were found outside those areas by a qc full re-screen.Customer reports this was the only false negative slide determined for month of february.No erroneous reports were sent out.Results were not confirmed by biopsy.Reporting for documentation.No follow up needed.Fp - 490398 - fp did not pick up low grade.

• Brand Name: BD FOCAL POINT"120V / 15 FOV (REFURBISHED)
• Type of Device: SEE H.10
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16513246
• MDR Text Key: 311053052
• Report Number: 1119779-2023-00260
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

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: 490398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/09/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 05/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1