MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD FOCAL POINT"120V / 15 FOV (REFURBISHED); PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Catalog Number 490398

Device Problem False Negative Result (1225)

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

Event Date 05/29/2023

Event Type  malfunction  

Event Description

It was reported that during use with the bd focal point"120v / 15 fov (refurbished), a false negative result was obtained.There was no report of patient impact.The following information was provided by the initial reporter: customer reports that on 5/29 there was a variance where low grade cells were found outside the areas designated by the focalpoint and were not flagged.Customer reports this was the only false negative slide determined recently in a set of 19.No erroneous reports were sent out.Results were not confirmed by biopsy.

Manufacturer Narrative

H6.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 may.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.

• Brand Name: BD FOCAL POINT"120V / 15 FOV (REFURBISHED)
• Type of Device: PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17159289
• MDR Text Key: 317911955
• Report Number: 1119779-2023-00681
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2023

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: 05/31/2023
• Initial Date FDA Received: 06/19/2023
• 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