BECTON, DICKINSON & CO. (SPARKS) PANEL PHOENIX NMIC-306; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
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Catalog Number 449292 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 panel phoenix nmic-306 false resistance was observed by the laboratory personnel.A gram stain was used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " lab reports show discrepant ertapenem results between microscan and phoenix results also show meropenem susceptible on microscan, but meropenem vaporbactam as r on phoenix.Customer reports sporadic meropenem issue as well in email from (b)(6) 2021.She reports they have incubated all broth tubes to make sure nothing grows.The repeat on the new lot number was set up on 3/19/21 ".
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Manufacturer Narrative
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Correction: b5: describe event or problem: it was reported that while using panel phoenix nmic-306 false resistance was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "lab reports show discrepant ertapenem results between microscan and phoenix results also show meropenem susceptible on microscan, but meropenem vaporbactam as r on phoenix customer reports sporadic meropenem issue as well in email from 3/19/2021.She reports they have incubated all broth tubes to make sure nothing grows.The repeat on the new lot number was set up on 3/19/2021" h6: investigation summary this complaint is for discrepant mic results for multiple drugs when using phoenix panel nmic-306 (449292) batch number 0350380.The customer did not provide any product samples, isolates, or lab reports for investigation.To investigate, a total of four (4) retention panels from the complaint batch were tested using qc isolates of klebsiella pneumoniae (a700603), escherichia coli (a25922), escherichia coli (a35218), and pseudomonas aeruginosa (a27853).One (1) panel was tested per qc isolate using a phoenix m50 instrument.During investigation, all panels yielded satisfactory mic results for all the drugs on the panel, per the package insert.Since all results during investigation were satisfactory the complaint is not confirmed.It is to be noted that a field applications specialist visited the site to investigate the customer's ap instrument.It was noted that the ap tubing was installed incorrectly.Decontamination and a reagent change was also performed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed two (2) additional complaints on the complaint batch, which are related to this complaint as it was reported by the same customer with different awareness dates.
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Event Description
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It was reported that while using panel phoenix nmic-306 false resistance was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "lab reports show discrepant ertapenem results between microscan and phoenix results also show meropenem susceptible on microscan, but meropenem vaporbactam as r on phoenix customer reports sporadic meropenem issue as well in email from 3/19/2021.She reports they have incubated all broth tubes to make sure nothing grows.The repeat on the new lot number was set up on 3/19/2021".
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