MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM; GRAM NEGATIVE IDENTIFICATION PANEL

Catalog Number	245000
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported while using bd bbl¿ crystal¿ enteric/nonfermenter id system klebsiella variicola was misidentified as k pneumoniae.There was no report of patient impact.The following information was provided by the initial reporter: customer reports unexpected id of klebsiella variicola as k pneumoniae no further follow up needed, customer was advised that k variicola is not in database taxa list for identification.
Additional Manufacturer Narrative
H6: investigation summary this complaint is for the mis-identification of klebsiella variicola as klebsiella pneumoniae.There are no claims for this organism as it is not in the phoenix id database.This complaint is not confirmed.A review of complaints revealed no additional complaints on this catch.A review of quality notifications revealed there were no quality notifications noted on this batch.
Event or Problem Description
It was reported while using bd bbl¿ crystal¿ enteric/nonfermenter id system klebsiella variicola was misidentified as k pneumoniae.There was no report of patient impact.The following information was provided by the initial reporter: customer reports unexpected id of klebsiella variicola as k pneumoniae no further follow up needed, customer was advised that k variicola is not in database taxa list for identification.

• Brand Name: BD BBL CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM
• Common Device Name: GRAM NEGATIVE IDENTIFICATION PANEL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11659348
• Report Number: 1119779-2021-00660
• Device Sequence Number: 14312156
• Product Code: JSS
• UDI-Device Identifier: 00382902450009
• UDI-Public: 00382902450009
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K926018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/19/2021

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
• Operator of Device: Other
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 245000
• Device Lot Number: 0066303
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1