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 03/25/2024

Event Type  malfunction  

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 when using the bd focal point"120v / 15 fov (refurbished) atypical cells were seen outside the field of vision when reviewing a patient slide 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

H.6.Investigation summary: the complaint alleges the bd focalpoint instrument had a "false negative result".The customer reported that there was a variance in result where a slide was reported negative with no abnormal cells located in the field of view (fov) but qc review by the technician determined there were atypical cells outside of the fov.Remote assistance was provided to the customer which involved review of historical data for this instrument.Analysis by bd revealed that the positivity rates for their screening results is within expected prevalence rates.A bd field service engineer (fse) was dispatched to the customer site to perform cleaning of the optics and adjustment of the coverslip thickness and offset calibration.The instrument was qualified successfully and confirmed to operate to bd specifications.This complaint is unconfirmed as no functional part failure was identified.The root cause is unable to be determined with the information provided.No samples were expected to be received as part of this complaint, and therefore no samples were returned, and no returned material investigation could occur.Review of the device history record for the instrument is not required because this complaint does not allege an early life failure or failure at installation and the complaint is unconfirmed, thus a dhr review would yield no useful information.Service history review was performed for the instrument and one additional case was observed on 11apr2024 for the complaint failure mode reported.Bd quality will continue to closely monitor for trends associated with this complaint.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.

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 a patient slide 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: 19169944
• MDR Text Key: 341690176
• Report Number: 1119779-2024-00311
• 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: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/03/2024

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: 03/25/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 06/03/2024
• Supplement Dates FDA Received: 06/12/2024
• Was Device Evaluated by Manufacturer?: No
• 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