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	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: na.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 has been reported that the bd kiestra inoqula has been found producing erroneous patient results during use.No patient impact was reported.
Event or Problem Description
It has been reported that the bd kiestra inoqula has been found producing erroneous patient results during use.No patient impact was 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 customer reported suspected contamination in thioglycolate tubes processed on the equipment, leading them to believe the instrument might be contributing to contamination.No other issues were reported.During the investigation, the field service engineer (fse) and the applications team reviewed the customer¿s cleaning and decontamination workflow, evaluated tube handling practices, and assessed equipment performance.It was determined that selenite and thioglycolate tubes were being placed in incorrect racks, and improper cleaning products were used.A dedicated rack for thioglycolate tubes (ref: 447793) was requested, and the applications team will configure and commission it.Equipment performance was verified as normal.Following this action, no further issues were encountered.Based on the investigation at the instrument level, this case has been assessed as confirmed, but not due to an instrument related bd quality issue.The confirmation relates solely to workflow practices external to the instrument.No new trends, risks, or hazards were identified as a result 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.The results of this evaluation have not identified any new hazards, new risks, or specific trends.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: 24471643
• Report Number: 3010141591-2026-00001
• Device Sequence Number: 9615865
• Product Code: JTC
• UDI-Device Identifier: 00382904472023
• UDI-Public: (01)00382904472023(11)181105
• 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): 03/24/2026

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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2018
• 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