MAUDE Adverse Event Report: BD KIESTRA LAB AUTOMATION BD KIESTRA INOCULATION SYSTEM; DEVICE, MICROTITER DILUTING/DISPENSING

Catalog Number	447202
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	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone #:(b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use with the bd kiestra inoculation system, there was possible contamination of the slide processing module which led to a false patient result.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary this statement is to summarize the investigation of a complaint involving the bd kiestra inoqula.According to the information provided, the bd kiestra inoqula-spm result did not match.No other issues were reported.During the investigation, bd noted that the bd kiestra inoqula-slide processing module (spm) result did not match.A research and development (r&d) specialist reviewed the logs and found no irregularities in the slide processing.According to the information provided, discussions with internal microbiology specialists could not explain the discrepancy between the slide result and the plate growth.However, it is believed that the handling actions of the inoqula+ are not the cause.The sample was inoculated without issues, and logs show normal processing of plates and slides.If contamination were from the pipettor or pipette tips, growth would be expected on the dishes, as the instrument inoculates all media in one run.Following this action, no further issues were encountered.Based on investigation, this case has been assessed as confirmed for a bd quality issue.Review found no new trends, risks, or hazards were identified because of this complaint.The issue in this complaint does not require the initiation of a corrective and preventative action (capa).A design history record (dhr) review is not required for this complaint.The complaint was evaluated via other elements of the investigation.Bd quality will continue to closely monitor for trends associated with this issue.
Event or Problem Description
It was reported that during use with the bd kiestra inoculation system, there was possible contamination of the slide processing module which led to a false patient result.There was no report of patient impact.

• Brand Name: BD KIESTRA INOCULATION SYSTEM
• Common Device Name: DEVICE, MICROTITER DILUTING/DISPENSING
• Manufacturer (Section D): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten ; NL
• Manufacturer (Section G): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten ; NL
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20586987
• Report Number: 3010141591-2024-00007
• Device Sequence Number: 8797378
• Product Code: JTC
• UDI-Device Identifier: 00382904472023
• UDI-Public: (01)00382904472023(11)210506
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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 Catalogue Number: 447202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown