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 07/20/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Initial reporter email address: (b)(6).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 by the customer that the had one false negative slide on bd focal point"120v / 15 fov (refurbished).There was one occurrence in this event with no patient impact.The following information was provided by the customer: "(b)(4)/ result issue".

Event Description

It was reported by the customer that the had one false negative slide on bd focal point"120v / 15 fov (refurbished).There was one occurrence in this event with no patient impact.The following information was provided by the customer: "(b)(6) / result issue".

Manufacturer Narrative

H.6 investigation summary: this complaint alleges a failure on the focalpoint instrument (p/n 490398, s/n (b)(6)).The customer reported a false negative result on their instrument, low grade cells were noted outside the field of view.Per the (b)(4) focalpoint gs false negative test work instruction with 1 false negative result 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.Once calculated it assigns a score called a k value.If the k value is greater than or equal to the number of false negative slides, the machine is performing within claims.Due to only 1 false negative result being reported this means the k value is within specification.This is an unconfirmed failure of the instrument.Samples were not received by quality for investigation and thus, returned material investigation could not occur.Review of device history record for instrument serial number, (b)(6) 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.Root cause is performance variation in optical system or fov.Per (b)(4) work instructions: false negative test ¿ focalpoint gs, a false negative (fn) is defined as ¿a patient slide that has been evaluated by fov only by the focalpoint gs¿, operating as labeled for primary screening that is later determined by manual review to be ascus+.¿ fov (field of view) only slides are ¿a category of patient slides that had only fovs reviewed during processing with no full slide review done.¿ and ¿all fovs were deemed normal, no abnormalities detected.¿ this is an unconfirmed failure of a bd product.Bd will continue to closely monitor trends associated with this complaint.Complaint history for results was reviewed for the month of september.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 corrective and preventative action (capa).This complaint will be included in the periodic trend review.H3 other text : see h.10.

• 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 ; 8015296192
• MDR Report Key: 15449818
• MDR Text Key: 306076599
• Report Number: 1119779-2022-01194
• 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: 11/16/2022

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: 09/01/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 11/23/2022
• 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