MAUDE Adverse Event Report: BD KIESTRA LAB AUTOMATION BD KIESTRA INOQULA; 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	08/06/2025
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.D4: medical device expiration date: n/a.
Event or Problem Description
It has been reported that the bd kiestra inoqula has been found producing erroneous results.No patient impact was reported.
Event or Problem Description
It has been reported that the bd kiestra inoqula has been found producing erroneous results.No patient impact was reported.
Additional Manufacturer Narrative
H.6.Investigation summary: this statement summarizes the investigation of a complaint involving the instrument bd kiestra inoqula.According to the information provided, the inoqula system incorrectly processed three urine samples, possibly due to contamination.No other issues were reported.During the investigation, the field service engineer (fse) observed that the inoqula system incorrectly processed three urine samples, possibly due to contamination.The client identified the issue as contamination from an isolated sample and confirmed plans to proceed with sequencing.The fse contacted the applications team for follow-up and provided cleaning guidelines for the inoqula system.Upon further follow-up, the client confirmed that the contamination originated from another instrument.The inoqula system was verified to be operational and functioning correctly according to bd performance criteria.Following this action, no further issues were encountered.Based on investigation, this case has been assessed as confirmed as 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 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 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 ; NL
• Manufacturer (Section G): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten ; NL
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22926873
• Report Number: 3010141591-2025-00005
• Device Sequence Number: 9079607
• Product Code: JTC
• UDI-Device Identifier: 00382904472023
• UDI-Public: (01)00382904472023(11)180315
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2025

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: 08/08/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown