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

Catalog Number 447202

Device Problem False Negative Result (1225)

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

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd kiestra inoqula there was false negative.There was no report of impact to patient or user.

Manufacturer Narrative

H6: investigation summary: this statement is to summarize the investigation of a complaint involving the bd kiestra inoqula (material # 447202 - serial #(b)(6)).According to information provided, ino samples were not inoculated.No other issues were reported.During the investigation, the field service engineer (fse) observed the issue and cleaned the pdv sensor and calibrated the pipette on the pdv using the teach button, which changed the value from 172 to 158.Later the fse verified all values concerning the zeus 2, template editor, and auto tech are verified (158).Also verified the pipettor alignment and functionality.The pdv sensor was tested by catching drops from the pipettor multiple times, resulting in an error each time; the samples were not inoculated, and the dishes were directed to the error stacker.The lid lifter vacuum cup was tested by drilling holes in the lids, which resulted in a vacuum error with each attempt.Following this the fse installed a camera to observe the pdv sensor and dispensing activities in future tests.Approximately 40 samples were tested, with three dishes per sample, and footage from the camera was reviewed.The fse confirmed that the pipettes are dispensing correctly, and the tip is not causing interference with the pdv sensor.Following this action, no further issues were encountered, and the instrument is working properly as per specifications.This is a confirmed complaint of the bd product.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 Description

It was reported when using the bd kiestra inoqula there was false negative.There was no report of impact to patient or user.

• Brand Name: BD KIESTRA INOQULA
• Type of Device: 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: 18641224
• MDR Text Key: 336057947
• Report Number: 3010141591-2024-00001
• Device Sequence Number: 1
• Product Code: JTC
• UDI-Device Identifier: 00382904472023
• UDI-Public: (01)00382904472023
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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
• Device Operator: Other
• Device Catalogue Number: 447202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1