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

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	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial address: (b)(6) h.6.Investigation summary: the customer reported on the bd kiestra inoqula material number: 447202 serial number: (b)(6).It was reported by the customer that there is random no growing in some inoculated dishes.A field service engineer (fse) went onsite and found that the pdv sensor was faulty.This confirmed the complaint.Later, the fse was performed the activities for resolving the issue such as checking the operation of pdv sensor, cleaning, performing functional tests and replacing with a new pdv sensor.After this, the issue has been resolved and now the instrument is back to 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).Device 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.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd kiestra inoqula obtained a false negative result.The following information was provided by the initial reporter: random no growing in some inoculated dishes.Can you kindly confirm if there is patient samples were involved? yes there were patient samples involved.I.Did the course of treatment change? if yes, provide details.The costumer is not aware of this happening.They identified that the pdv might be failing because they saw some samples where the abundance of bacteria in gram stained slides did not match the absence of growth in the other plates for that patient.Because they have the gram stain as a doublecheck, they manually inoculated the samples again for a second time in the same kind of plates and there was growth.The only change for this samples would have been a delay in reporting results back.More samples without gram stain might have been affected but the costumer was not aware of it.Ii.Were there erroneous results? if yes, provide details.Again the costumer realized in the samples with the gram, and doesn¿t know if any false negative might have gone outin samples without gram.As far as we know, there were no erroneous results reported.Iii.Was there exposure to blood/bodily fluid? if yes, provide details.No iv.Was there medical intervention? if yes, provide details.No.
Additional Manufacturer Narrative
The mdr mfr.# 3010141591-2023-00003 was sent in error.Review of the event with the subject matter experts in the business unit indicate that this was a "no inoculation" event and as such is not reportable.The record should be considered canceled.See h.10.
Event or Problem Description
It was reported that the bd kiestra inoqula obtained a false negative result.The following information was provided by the initial reporter: random no growing in some inoculated dishes.Can you kindly confirm if there is patient samples were involved? yes there were patient samples involved.I.Did the course of treatment change? if yes, provide details.The costumer is not aware of this happening.They identified that the pdv might be failing because they saw some samples where the abundance of bacteria in gram stained slides did not match the absence of growth in the other plates for that patient.Because they have the gram stain as a doublecheck, they manually inoculated the samples again for a second time in the same kind of plates and there was growth.The only change for this samples would have been a delay in reporting results back.More samples without gram stain might have been affected but the costumer was not aware of it.Ii.Were there erroneous results? if yes, provide details.Again the costumer realized in the samples with the gram, and doesn¿t know if any false negative might have gone outin samples without gram.As far as we know, there were no erroneous results reported.Iii.Was there exposure to blood/bodily fluid? if yes, provide details.No iv.Was there medical intervention? if yes, provide details.No.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17278430
• Report Number: 3010141591-2023-00003
• Device Sequence Number: 5281127
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: Health Professional
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 07/12/2023
• 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