MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX AST-S INDICATOR SOLUTION; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Model Number	246009
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	03/16/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that while using 15 bd phoenix¿ ast-s indicator solution atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "customer is reporting aborted panels due to insufficient indicator." the following information was provided by the initial reporter: " material no: 246009.Lot no: 0226723.It was reported that aborted panels due to insufficient indicator occurred.".
Additional Manufacturer Narrative
After further review it was determined that this mdr was incorrectly submitted and should be considered cancelled.The test result obtained by the laboratory personnel was no identification which is not an erroneous result and is therefore not a reportable event.
Event or Problem Description
It was reported that while using 15 bd phoenix¿ ast-s indicator solution atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "customer is reporting aborted panels due to insufficient indicator." material no: 246009 lot no: 0226723 it was reported that aborted panels due to insufficient indicator occurred.".

• Brand Name: BD PHOENIX AST-S INDICATOR SOLUTION
• Common Device Name: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11645004
• Report Number: 1119779-2021-00641
• Device Sequence Number: 19578722
• Product Code: LON
• UDI-Device Identifier: 30382902460092
• UDI-Public: 30382902460092
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K050745
• 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): 04/27/2021

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: 05/31/2021
• Device Model Number: 246009
• Device Catalogue Number: 246009
• Device Lot Number: 0226723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1