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Model 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 12/14/2022 |
Event Type
malfunction
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Event Description
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It was reported that while using the panel phoenix nmic/id-307 that there was misidentification.The following information was provided by the initial reporter: it was reported by the customer that they have had issues with e.Coli 35218 qc, where the panel passed, but the id is citrobacter farmeri.Customer problem: misidentified organisms.Customer location (country): us.Steps taken with customer/troubleshooting: customer initially stated that they have had issues with e.Coli 35218 qc, where the panel passed, but the id is citrobacter farmeri.Advised that organism is only for 2 drugs on the panel.Customer later stated that they have had some patient isolates of e.Coli that also identify as citrobacter.Isolates are sent to for id.Customer could not provide an incident start date, or approximation.Requested lab reports.Emailing instructions to save binary files.Emailing additional questions.
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Manufacturer Narrative
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Common device name: system, test, automated antimicrobial susceptibility.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Initial reporter phone #: (b)(6).
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Manufacturer Narrative
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Mfr report # follow up # 1 was sent in error.There were misidentified patient samples which is a reportable event and there were misidentified qc panel results that are not reportable.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that while using the panel phoenix nmic/id-307 that there was misidentification.The following information was provided by the initial reporter: it was reported by the customer that they have had issues with e.Coli 35218 qc, where the panel passed, but the id is (b)(6).Customer problem: misidentified organisms.Customer location (country): us.Steps taken with customer/troubleshooting: customer initially stated that they have had issues with e.Coli 35218 qc, where the panel passed, but the id is cirtobacter farmeri.Advised that organism is only for 2 drugs on the panel.Customer later stated that they have had some patient isolates of e.Coli that also identify as citrobacter.Isolates are sent to for id.Customer could not provide an incident start date, or approximation.Requested lab reports.Emailing instructions to save binary files.Emailing additional questions.
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Manufacturer Narrative
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H6 investigation summary: this complaint is not confirmed.This complaint is for qc and clinical failures due to misidentification of e.Coli as citrobacter when using phoenix panel nmic/id-307 (449289) batch number 2249522.The customer returned panels, lab reports and isolates for the investigation.Customer returned five (5) panels and four (4) isolates but one was a gram positive isolate, whereas this complaint is logged against a gram negative panel.The other three (3) isolates were used for testing.To investigate, a customer returned panel from the complaint batch was tested using customer returned isolate e.Coli (m-07) and evaluated for identification results.In addition, two (2) customer returned panels from the complaint batch were tested using customer returned isolates e.Coli (m-24) and e.Coli (m-91) and evaluated for identification results.During investigation, all panels identified correctly as e.Coli.Therefore, this complaint is not confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed three (3) additional complaints on the complaint batch, related to this defect.Complaint trending was performed and no trends were identified associated with this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.Please continue to communicate any additional concerns.Bd encourages you to consider the following parameters to optimize results within your laboratory.Qc testing should only be performed on 2nd pass subcultures and avoid using colonies that have been sub-cultured multiple times.Isolated colonies are to be used for inoculation and carefully check purity plates to ensure the inoculum consisted of one isolate type.Optimum performance comes from using fresh 18-24 hour, well-isolated colonies.Ensure proper, sufficient inoculum density: allow bubbles to dissipate after vortexing.Properly calibrate the bd phoenixspec¿ nephelometer with in-date mcfarland calibration standards.Use swabs with minimal fiber shed.Make the proper inoculum density for the inoculum system setting (i.E., if preparing a 0.25 mcfarland inoculum, ensure that the system is set to 0.5 inoculum mode).Volume of id broth should be visually assessed for any obvious low fills.Ensure proper incubation temperature and environment.Use the correct media type as listed as acceptable for use in the user¿s manual (note - it is helpful to disclose the media type and vendor when providing the details of the complaint).Handle panels by only touching the sides; touching the front or back of the panels may cause interference in the readings and lead to errors.Follow user¿s manual instructions for time limits on pouring inoculated id broth into the panel and placing the panel into the instrument; extended periods of time outside of the stated limitations may yield errors.
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Event Description
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It was reported that while using the panel phoenix nmic/id-307 that there was misidentification.The following information was provided by the initial reporter: it was reported by the customer that they have had issues with e.Coli 35218 qc, where the panel passed, but the id is cirtobacter farmeri.Customer problem: misidentified organisms.Customer location (country): us.Steps taken with customer/troubleshooting: customer initially stated that they have had issues with e.Coli 35218 qc, where the panel passed, but the id is cirtobacter farmeri.Advised that organism is only for 2 drugs on the panel.Customer later stated that they have had some patient isolates of e.Coli that also identify as citrobacter.Isolates are sent to for id.Customer could not provide an incident start date, or approximation.Requested lab reports.Emailing instructions to save binary files.Emailing additional questions.
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Manufacturer Narrative
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After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2022-01532 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.See h.10.
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Event Description
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It was reported that while using the panel phoenix nmic/id-307 that there was misidentification.The following information was provided by the initial reporter: it was reported by the customer that they have had issues with e.Coli 35218 qc, where the panel passed, but the id is cirtobacter farmeri.¿ customer problem: misidentified organisms.¿ customer location (country): us ¿ steps taken with customer/troubleshooting: customer initially stated that they have had issues with e.Coli 35218 qc, where the panel passed, but the id is cirtobacter farmeri.Advised that organism is only for 2 drugs on the panel.Customer later stated that they have had some patient isolates of e.Coli that also identify as citrobacter.Isolates are sent to for id.Customer could not provide an incident start date, or approximation.Requested lab reports.Emailing instructions to save binary files.Emailing additional questions.
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