BECTON, DICKINSON & CO. (SPARKS) PANEL PHOENIX NMIC/ID-307; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY
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Catalog Number 449289 |
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 12/02/2023 |
Event Type
malfunction
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Event Description
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It was reported that during use with the panel phoenix nmic/id-307, a patient sample of e.Coli was misidentified as citrobacter freundii.There was no report of patient impact.Report 1 of 4.
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Manufacturer Narrative
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G5.The panel phoenix nmic/id-307 is a panel that consists of a combination of the following 510k numbers: k020322, k023444, k023634, k023858, k024153, k031530, k031699, k032299, k032655, k033560, k041384, k042932, k052269, k060214, k060217, k060444, k060447, k060447, k061355, k062944, k063301, k063573, k063811, k063824, k071623, k132674, k151320 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 panel phoenix nmic/id-307, a patient sample of e.Coli was misidentified as citrobacter farmeri.There was no report of patient impact.Report 1 of 4.
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Manufacturer Narrative
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H.6.Investigation summary: this complaint is for misidentification of proteus mirabilis and escherichia coli as citrobacter species and providencia rettgeri when using phoenix panel nmic/id-307 (catalog number 449289) batch number 3241315.The customer returned panels, isolates and phoenix generated lab reports for the investigation.The customer provided phoenix lab reports show an isolate identified as p.Mirabilis, e.Coli, c.Farmeri, c.Freundii and p.Rettgeri when using the complaint batch.Isolate 33500361 was not a pure culture and not used in investigatin testing.The other four customer returned isolates were verified on a bruker maldi biotyper and labeled as p.Mirabilis sq-7, e.Coli sq-8, e.Coli sq-10 and e.Coli sq-12.To investigate, retention and customer returned panels from the complaint batch were tested using customer returned isolates p.Mirabilis sq-7, e.Coli sq-8, e.Coli sq-10 and e.Coli sq-12 on a phoenix m50 machine and evaluated for identification results.In addition, one control panel from the same material but different batch was tested using customer returned isolates p.Mirabilis sq-7, e.Coli sq-8, e.Coli sq-10 and e.Coli sq-12 on a phoenix m50 machine and evaluated for identification results.The twelve panels tested identified their inoculated isolate correctly, therefore, this complaint is not confirmed for misidentification.The batch history record was satisfactory and no quality notifications were generated during manufacturing and inspection.A review of complaints revealed seven additional complaint on the complaint batch, four of which are related to this defect and unconfirmed.Complaint trending was performed, and no trends were identified associated with this defect.Bd will continue to monitor for trends and take action as necessary.Please continue to communicate any additional concerns.Thank you again for contacting bd and please continue to communicate any further concerns.H3 other text : see h.10.
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