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

Catalog Number	447202
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 the bd kiestra inoqula did not dispense sample on plates resulting in no growth.There was no health impact or consequences reported.
Event or Problem Description
It was reported that the bd kiestra inoqula did not dispense sample on plates resulting in no growth.There was no health impact or consequences reported.
Additional Manufacturer Narrative
H.6 investigation summary this statement is to summarize the investigation of a complaint involving the bd kiestra inoqula.According to the information provided, the issue was reported that there were plates found with no growth.During the investigation, it was reported that after previous occurrences, a camera was installed to monitor the situation.After the camera was installed, the customer reported again an occurrence of the issue.The issue was escalated to the system support specialist (sss) and research and development (r&d) for further investigation.The photos of the negative plates were retrieved, were reviewed by r&d, and showed that the beads went through the plate.Despite the issue reoccurring, the customer transitioned from the old zeus to the zeus ii system and the issue did not reoccur after this change.Following this action, no further issues were encountered.Based on the 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.

• Brand Name: BD KIESTRA INOQULA
• Common Device Name: DEVICE, MICROTITER DILUTING/DISPENSING
• Manufacturer (Section D): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten KY
• Manufacturer (Section G): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten KY
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18722776
• Report Number: 3010141591-2024-00002
• Device Sequence Number: 6310632
• Product Code: JTC
• UDI-Device Identifier: 00382904472023
• UDI-Public: (01)00382904472023
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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: 01/26/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2021
• 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