BECTON DICKINSON & CO. (SPARKS) BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
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Catalog 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 02/12/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.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 when using the bd phoenix¿ m50 automated microbiology system, enterobacter cloacae was misidentified in an unspecified number of samples.After culture and repeat testing, the expected result of escherichia coli was identified.There was no report of patient impact.
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Event Description
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It was reported when using the bd phoenix¿ m50 automated microbiology system, enterobacter cloacae was misidentified in an unspecified number of samples.After culture and repeat testing, the expected result of escherichia coli was identified.There was no report of patient impact.
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Manufacturer Narrative
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H6.Investigation summary: a results failure was reported on a phoenix m50 instrument.The customer reported erroneous identification of a microorganism.A field service engineer (fse) arrived onsite to troubleshoot the instrument.The fse found the instrument to be error free and functioning as expected.The fse performed a decontamination of the equipment, verified the temperature is in range, verified the electrical outlets and voltage is adequate, performed a software update, cleaned normalizers, lenses, light source boards.The light source boards were adjusted and the normalizer cv was performed and acceptable.The instrument was returned to the customer in working order.The root cause of the failure is not known.This is an unconfirmed failure of a bd product.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 for this instrument was reviewed and revealed case #'s (b)(4) related to this failure mode.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.
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Search Alerts/Recalls
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