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 12/13/2023

Event Type  malfunction  

Event Description

It was reported that the bd focal point 120v / 15 fov (refurbished) gave a false negative result.No health impact or consequence reported.

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd focal point 120v / 15 fov (refurbished) gave a false negative result.No health impact or consequence reported.

Manufacturer Narrative

Investigation summary: this complaint alleges false negative result on the focalpoint instrument.The customer called in to report that they found low grade cells on the slide during qc review.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.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.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.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18494937
• MDR Text Key: 332877025
• Report Number: 1119779-2023-01494
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 00382904903985
• UDI-Public: (01)00382904903985
• 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,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• 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
• Date Manufacturer Received: 03/15/2024
• 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