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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX NMIC-501; SYSTEM, TEST, AUTO, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
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BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX NMIC-501; SYSTEM, TEST, AUTO, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION Back to Search Results
Catalog Number 449041
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone #: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported while using bd phoenix¿ nmic-501 2 strains k.Pneumoniae carrying the resistance mechanism kpc and sensitive ceftazidime / avibactam, were passed through the nmic 501 panel obtaining erroneous results.Resulting mbl and resistant ceftazidime / avibactam.The strains were confirmed as carriers of kpc discs and the carriage of mbl was ruled out.No treatment based on erroneous results.The following information was provided by the initial reporter: strain1: from urine culture: sensitivity is performed using the phoenix nmic-501 panel and disc antibiogram.The mechanism was confirmed using synergy with boronic acid and edta, testing positive only with boronic acid and also using the kit: kpc, mbl and oxa-48 confirm kit: carbapenemases from rosco.The determination of sensitivity to ceftazidime avibactam was performed with liofilchem brand discs, resulting in sensitive by disc and resistant by panel.Strain 2: from tracheal aspirate: sensitivity is performed using the phoenix nmic-501 panel and manually.The mechanism was confirmed using synergy with boronic acid and edta, testing positive only with boronic acid and also using the kit: kpc, mbl and oxa-48 confirm kit: carbapenemases rosco.The sensitivity to ceftazidime avibactam was sensitive by both methodologies.In both strains, the nmic-501 panel detected an mbl mechanism, instead, manually, only the presence of kpc-type carbapenemase was observed.
 
Manufacturer Narrative
Investigation summary: this complaint investigation is only applicable to exus panel formats only.This complaint is for incorrect ambler classification as well as false resistance of ceftazidime / avibactam when using nmic 501 (449041) batch 0071520.Lab report results were provided by the customer, but no product returns or isolates were provided for investigation.It is to be noted that an alternate method was used for this patient.To investigate, a total of three retention panels from this complaint batch were tested using a phoenix 100 instrument.One panel was tested for class a (kpc) using qc isolate klebsiella pneumoniae atcc 14780), and yielded the correct result of class a.One panel was tested for class b (ndm) using in house isolate escherichia coli 18187, and yielded the correct result of class b.One complaint was tested for cpo negative using qc isolate escherichia coli a25922, and yielded the correct result of cpo negative.Additionally, all three panels were tested for ceftazidime / avibactam and yielded the correct mics per the package insert.This complaint is not confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed two additional complaints on the complaint batch.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.
 
Event Description
It was reported while using bd phoenix¿ nmic-501 2 strains k.Pneumoniae carrying the resistance mechanism kpc and sensitive ceftazidime / avibactam, were passed through the nmic 501 panel obtaining erroneous results.Resulting mbl and resistant ceftazidime / avibactam.The strains were confirmed as carriers of kpc discs and the carriage of mbl was ruled out.No treatment based on erroneous results.The following information was provided by the initial reporter: strain1: from urine culture: sensitivity is performed using the phoenix nmic-501 panel and disc antibiogram.The mechanism was confirmed using synergy with boronic acid and edta, testing positive only with boronic acid and also using the kit: kpc, mbl and oxa-48 confirm kit: carbapenemases from rosco.The determination of sensitivity to ceftazidime avibactam was performed with liofilchem brand discs, resulting in sensitive by disc and resistant by panel.Strain 2: from tracheal aspirate: sensitivity is performed using the phoenix nmic-501 panel and manually.The mechanism was confirmed using synergy with boronic acid and edta, testing positive only with boronic acid and also using the kit: kpc, mbl and oxa-48 confirm kit: carbapenemases rosco.The sensitivity to ceftazidime avibactam was sensitive by both methodologies.In both strains, the nmic-501 panel detected an mbl mechanism, instead, manually, only the presence of kpc-type carbapenemase was observed.
 
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Brand Name
BD PHOENIX NMIC-501
Type of Device
SYSTEM, TEST, AUTO, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
MDR Report Key11337919
MDR Text Key245752439
Report Number1119779-2021-00317
Device Sequence Number1
Product Code LON
Combination Product (y/n)N
PMA/PMN Number
K163637
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2021
Device Catalogue Number449041
Device Lot Number0071520
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/25/2021
Initial Date FDA Received02/17/2021
Supplement Dates Manufacturer Received04/02/2021
Supplement Dates FDA Received04/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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