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

Catalog Number 245000

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/24/2021

Event Type  malfunction  

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 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.

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 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
• Type of Device: GRAM NEGATIVE IDENTIFICATION PANEL
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11659348
• MDR Text Key: 251398183
• Report Number: 1119779-2021-00660
• Device Sequence Number: 1
• Product Code: JSS
• UDI-Device Identifier: 00382902450009
• UDI-Public: 00382902450009
• Combination Product (y/n): N
• PMA/PMN Number: K926018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 245000
• Device Lot Number: 0066303
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1