MAUDE Adverse Event Report: BECTON, DICKINSON & CO. PANEL PHOENIX NMIC ID 304; IDENTIFICATION/SUSCEPTIBILITY

Model Number	448743
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional 510k number: k040099, k131331.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that while using the panel phoenix nmic id 304, an erroneous results was reported.The panel used, misidentified klebsiella aerogenes as enterobacter cloacae.Patient results were reported and the patient received treatment.Confirmatory testing was performed and a corrected report was sent to the physician.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 6/8/2020 h.6.Investigation: this complaint is for the mis-identification of klebsiella aerogenes as enterobacter cloacae when using phoenix panel nmic/id 304 batch 0022657.The customer provided two isolates for investigation.No product returns were provided.A review of quality notifications revealed no quality notifications generated on the complaint batch.Complaint trending was performed and no trends were identified for this defect.The first isolate provided by the customer was tested on four retention panels from the complaint batch and one panel from a separate batch.All tested panels yielded the expected identification result of k.Aerogenes.The second isolate provided by the customer was tested on three retention panels from the complaint batch and two panels from a separate batch.All panels tested with this isolate yielded the identification result of enterobacter cloacae.Testing of internal and any returned material per the phoenix¿ user¿s manual confirmed discrepant results.The frequency of this complaint has been assessed and has been determined to fall below the threshold level of an actionable trend.Bd will continue to monitor all complaints and take appropriate action should the level exceed required thresholds.For all complaints related to identification, bd provides the following list of parameters that optimize laboratory results: 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 root cause was not determined.H3 other text : see h.10.
Event or Problem Description
It was reported that while using the panel phoenix nmic id 304, an erroneous results was reported.The panel used, misidentified klebsiella aerogenes as enterobacter cloacae.Patient results were reported and the patient received treatment.Confirmatory testing was performed and a corrected report was sent to the physician.

• Brand Name: PANEL PHOENIX NMIC ID 304
• Common Device Name: IDENTIFICATION/SUSCEPTIBILITY
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 10159615
• Report Number: 1119779-2020-00142
• Device Sequence Number: 3468290
• Product Code: LON
• UDI-Device Identifier: 30382904487431
• UDI-Public: 30382904487431
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K020321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2021
• Device Model Number: 448743
• Device Catalogue Number: 448743
• Device Lot Number: 0022657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other