MAUDE Adverse Event Report: BD KIESTRA LAB AUTOMATION BD KIESTRA INOQULA

Model Number	447202
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reported phone: (b)(6).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 was reported that bd kiestra inoqula pdv sensor dirty could cause potential false negative results.The following information was provided by the initial reporter: pdv sensor dirty and not cleaned as per user manual.Cleaning allows sensor to operate correctly.There were instances observed were the inoqula was "inoculating" some plates where no microorganism was growing.The costumer could see bacteria in the gram slide for them and if they inoculated the microorganism in semiautomated mode or manually there was growth.So those plates could be seen as negative when in reality they would be false negatives.
Additional Manufacturer Narrative
H6: investigation summary: the customer reported on the bd kiestra inoqula material number: 447202; serial number: (b)(6).It was reported that pvd failure that could go undetected.A system support engineer (sse) connected to the system remotely and found that the dirt was present in the sensor and not cleaned as per user manual.This confirmed the complaint.The sse advised the customer to clean the sensor.After this, the issue has been resolved and now the instrument is ready for routine use.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).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 for trends associated with this issue.
Event or Problem Description
It was reported that bd kiestra inoqula pdv sensor dirty could cause potential false negative results.The following information was provided by the initial reporter: pdv sensor dirty and not cleaned as per user manual.Cleaning allows sensor to operate correctly.There were instances observed were the inoqula was "inoculating" some plates where no microorganism was growing.The costumer could see bacteria in the gram slide for them and if they inoculated the microorganism in semiautomated mode or manually there was growth.So those plates could be seen as negative when in reality they would be false negatives.

• Brand Name: BD KIESTRA INOQULA
• Common Device Name: NA
• Manufacturer (Section D): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten
• Manufacturer (Section G): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16504769
• Report Number: 3010141591-2023-00001
• Device Sequence Number: 12317332
• Product Code: JTC
• UDI-Device Identifier: 00382904472023
• UDI-Public: 00382904472023
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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 Model Number: 447202
• 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: 02/22/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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