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 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

H3.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 when using the bd focal point"120v / 15 fov (refurbished) atypical cells were seen outside the field of vision when reviewing patient slides during quality control testing, resulting in a false negative.Additional testing was performed; however, the result of the testing is unavailable.No health impact or consequence reported.

Manufacturer Narrative

1119779-2024-00069-1 investigation summary: this complaint alleges false negative result on the focalpoint refurbished instrument (catalog number 490398) serial number (b)(6).The customer reported a circumstance were a slide reported negative with no abnormal cells located in the field of view (fov).Qc review determined there were atypical cells located outside the fov.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.The work instruction provides methodology for determining whether the system is operating within the product insert claims base on clinical trial data.Root cause not determined, and this complaint is not a confirmed failure of the instrument based on no sample returned for investigation.Samples were not received by quality for investigation and thus, returned material investigation could not occur.Review of device history record for focalpoint review station instrument is not required because this complaint does allege an early life failure but was initially installed on 02/05/2010 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.Review of risk management files confirms there are no new or modified risks associated with this failure mode.There are no corrective action plans or other corrections occurring.Bd quality will continue to monitor for trends associated with failure of "results.".

Event Description

It was reported when using the bd focal point"120v / 15 fov (refurbished) atypical cells were seen outside the field of vision when reviewing patient slides during quality control testing, resulting in a false negative.Additional testing was performed; however, the result of the testing is unavailable.No health impact or consequence reported.

• 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: 18639195
• MDR Text Key: 334673404
• Report Number: 1119779-2024-00069
• 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,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• 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: 03/01/2024
• 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