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

Model Number	491464
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while testing with bd instrument focalpoint ce universal a false negative result was obtained.Pathologist reviewed, and it turned out to be a non (b)(6)associated cervical adeno carcinoma of the gastric type.There was no report of patient impact.The following information was provided by the initial reporter: a pap smear was classified by focalpoint as no further review.After reviewing by a cyto tech and a pathologist, it turned out to be a non (b)(6) associated cervical adeno carcinoma of the gastric type.
Additional Manufacturer Narrative
H6: investigation summary this complaint alleges a false negative result on the focalpoint instrument (p/n 491464, s/n (b)(6).The customer called in to report that during qc screening they found non hpv related cervical adenocarcinoma on the slide.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, (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.Device was installed on (b)(6) 2018.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 sample 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 october.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 testing with bd instrument focalpoint ce universal a false negative result was obtained.Pathologist reviewed, and it turned out to be a non hpv associated cervical adeno carcinoma of the gastric type.There was no report of patient impact.The following information was provided by the initial reporter: a pap smear was classified by focalpoint as no further review.After reviewing by a cyto tech and a pathologist, it turned out to be a non hpv associated cervical adeno carcinoma of the gastric type.

• Brand Name: BD INSTRUMENT FOCALPOINT CE UNIVERSAL
• 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: 12800572
• Report Number: 1119779-2021-01805
• Device Sequence Number: 14620944
• Product Code: MNM
• UDI-Device Identifier: 00382904914646
• UDI-Public: 00382904914646
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Foreign,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: 491464
• Device Catalogue Number: 491464
• 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: 10/15/2021
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2018
• 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