MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) INSTRUMENT FOCALPOINT 120V; READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Model Number	491086
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: na.
Event or Problem Description
It was reported that while using instrument focal point 120v false negative results were obtained by the laboratory personnel.The customer stated there was no patient impact.The following information was provided by the initial reporter: "it was reported that abnormal cells outside of fov's".
Additional Manufacturer Narrative
H6: investigation summary this complaint alleges abnormal cells found outside the field of view (fov) on the focalpoint instrument (p/n 491086, s/n (b)(6).The customer called in to report that during regular qc screening they found lgsil cells on the slide outside of the 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 for instrument serial number, fp0832 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.Device was installed on may 24 2019.Service history review was performed for the instrument (b)(6) and no additional work orders were observed for the complaint failure mode reported.Root cause cannot be determined at this time as return material was not received for investigation.This complaint is unconfirmed as the samples 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 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 capa.This complaint will be included in the periodic trend review.
Event or Problem Description
It was reported that while using instrument focalpoint 120v false negative results were obtained by the laboratory personnel.The customer stated there was no patient impact.The following information was provided by the initial reporter: "it was reported that abnormal cells outside of fov's".

• Brand Name: INSTRUMENT FOCALPOINT 120V
• Common Device Name: READER, 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12634759
• Report Number: 1119779-2021-01654
• Device Sequence Number: 11822091
• Product Code: MNM
• UDI-Device Identifier: 00382904910860
• UDI-Public: 00382904910860
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P950009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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
• Operator of Device: Other
• Device Model Number: 491086
• Device Catalogue Number: 491086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown