MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PANEL PHOENIX NMIC-306; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY

Catalog Number 449292

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2021

Event Type  malfunction  

Event Description

It was reported that while using bd panel (b)(6) false positive results were obtained by the laboratory personnel.A state lab test is used to confirm the results.The customer stated results were reported out, but there was no report of patient impact.The following information was provided by the initial reporter: "it was reported that discrepancy in cpo detection of 1 isolates of serratia marcescens with use of (b)(6)panels.".

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd panel phoenix nmic-306 false positive results were obtained by the laboratory personnel.A state lab test is used to confirm the results.The customer stated results were reported out, but there was no report of patient impact.The following information was provided by the initial reporter: "it was reported that discrepancy in cpo detection of 1 isolates of serratia marcescens with use of nmic 306 panels.".

Manufacturer Narrative

H6: investigation summary: this complaint is for discrepant cpo detection of serratia marcescens when using phoenix panel nmic-306 (449292) batch number 1196720.The customer did return isolates and lab reports for investigation, however no panels were returned.To investigate, a total of six retention panels from the complaint batch were tested on a phoenix m50 instrument.The retention panels were tested using the following qc isolates: enf18981 (pseudomonas aeruginosa) and a25922 (escherichia coli).One customer returned isolate, 79768 (serratia marcescens) was tested in addition to the qc isolates.Two panels were tested per isolate and evaluated for ambler classification results.During investigation, all panels tested using isolates a25922 and customer returned 79768 did not classify as class b carbapenemase producers.All panels tested using isolates enf18981 did classify as class b carbapenemase producers as expected.This complaint is not confirmed.In addition to the quality investigation performed, r&d investigated using the customer returned isolates.Internal r&d testing did not confirm cpo false positive or class b false positive results for 2 out of 2 isolates.Serratia marcescens yielded susceptible mics to ipm, mem, etp, cza and ct on bmd.Pseudomonas aeruginosa yielded resistant mics to ipm and mem, while yielding susceptible results for cza and ct on bmd.Pseudomonas aeruginosa has intrinsic resistance to etp.Although all carbapenem microbials are resistant for pseudomonas aeruginosa, it has the potential to be a carbapenemase producing organism but cannot be confirmed without pcr testing.However, it is unlikely that both strains are carbapenemase producing organisms since mcim was negative.Furthermore, both isolates produced resistance to 3rd generation cephalosporins (caz and cro) and atm, which suggests other resistance mechanisms such as amp c beta-lactamase production and/or reduced porin expression.  cloxacillin (clx) is a class c beta-lactamase inhibitor and is added in combination with mem on the cpo detect test to reduce background beta-lactamase activity that can confound the panel.It can be concluded that the cpo detect test on nmic-306 and nmic-307 panel produced false cpo positive results, because mem61d (mem+clx) well did not effectively inhibit amp c production in the strains.A review of quality notifications revealed no quality notifications for the complaint batch.  a review of complaints revealed two additional complaints for 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.

• Brand Name: BD PANEL PHOENIX NMIC-306
• Type of Device: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12816921
• MDR Text Key: 285538003
• Report Number: 1119779-2021-01819
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 449292
• Device Lot Number: 1196720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1