BECTON, DICKINSON & CO. (SPARKS) BD FOCAL POINT 120V / 15 FOV (REFURBISHED); PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
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Catalog Number 490398 |
Device Problem
False Negative Result (1225)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that during use with the bd focal point 120v / 15 fov (refurbished), a false negative result was obtained.There was no report of patient impact.The following information was provided by the initial reporter: customer reports that on 6/21 there was a variance where low grade cells were found outside the areas designated by the focal point and were not flagged.Hazard, injury or erroneous results?: yes.Hazard, injury or erroneous results details customer reports this was the only false negative slide.No erroneous reports were sent out.Results were not confirmed by biopsy.
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Event Description
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It was reported that during use with the bd focal point 120v / 15 fov (refurbished), a false negative result was obtained.There was no report of patient impact.The following information was provided by the initial reporter: customer reports that on 6/21 there was a variance where low grade cells were found outside the areas designated by the focal point and were not flagged.Hazard, injury or erroneous results? yes hazard, injury or erroneous results details customer reports this was the only false negative slide.No erroneous reports were sent out.Results were not confirmed by biopsy.
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Manufacturer Narrative
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H.6.Investigation summary: this complaint alleges false negative result on the focalpoint instrument (p/n 490398, s/n (b)(6).The customer called in to report that they found low grade cells on the slide outside of the field of view (fov's).The initial report was corrected before results were sent to the patient and results were not confirmed by biopsy.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 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.The root cause is unknown at this time.This complaint is unconfirmed as the sample was not returned for investigation.
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