BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM; SEE H.10
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Model Number 443624 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Common device name: system, test, automated antimicrobial susceptibility, short incubation 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 while using the bd phoenix¿ m50 automated microbiology system that there was misidentification.The following information was provided by the initial reporter: the application specialist requires instrumental verification associated with his support for identification problem investigations.
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Manufacturer Narrative
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"a failure for mis-identification of results was reported on a phoenix m50 instrument (p/n 443624, s/n (b)(6) ).An application specialist requested verification of the m50 instrument while troubleshooting a mis-identification issue.The field service engineer (fse) arrived onsite to troubleshoot the instrument.The fse performed an instrument check, completed general cleaning of the instrument and cleaning of the optics.Colormetric calibration and verification was completed.The fse also replaced normalizers and lightsource and the expiration date was approaching.The instrument was found to operating as expected and preventative measures only were carried out.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.Dhr review is not required for this complaint as this complaint does not allege an early life failure or failure at installation and the configuration has changed since release from manufacturing due to service repairs/pms.Service history review was completed and revealed no further cases related to this failure mode, outside ot the one already described above.Complaints for results are within statistical control for the month of january 2023.The upper control limit was not breached.Quality will continue to monitor the results complaints for phoenix m50 instruments.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.H3 other text : see h.10.
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Event Description
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It was reported that while using the bd phoenix¿ m50 automated microbiology system that there was misidentification.The following information was provided by the initial reporter: the application specialist requires instrumental verification associated with his support for identification problem investigations.
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