MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD KIESTRA INOQULA+ TLA; MICROBIAL SPECIMEN INOCULATION

Model Number	447213
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
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.(b)(4).
Event or Problem Description
It was reported while using a bd kiestra¿ inoqula tla¿ to process patient samples a failure to inoculate specimen plates occurred for 6 samples.The laboratory initially interpreted the un-inoculated plates as negative, and reported results as such.Upon retesting the samples manually the laboratory confirmed the correct growth results were obtained.The issue resulted in a 2 day delay for the growth identification and corrected lab reports.No adverse medical impact was reported with regards to patients due to this issue.
Additional Manufacturer Narrative
H.6.Investigation: the customer informed the bd customer service desk that while using the inoqula to process patient samples, a failure occurred to inoculate specimen on bi-plates for 6 samples associated to 6 patients.The laboratory initially interpreted the uninoculated plates as negative and reported results as such.Upon retesting the samples manually, the laboratory confirmed the correct growth results were obtained.No adverse medical impact was reported with regards to patients due to this issue.The investigation was initially focused on the configuration and history of the inoqula.The inoqula is equipped with pdv (positive dispense verification) and this was operational at the time of the issue according the field service engineer per interview on 10/jul/2020.At the time of the issue, the inoqula ran on software version 20.3.102.402.On 28/may/2020, the center for bi-plate detection was defect and replaced by bd field service.The fse recalibrated the bi-plate detection, performed oq and confirmed effectiveness.Three days later (31/may/2020), bd field service was dispatched to the barcoda.On site, the customer asked field service to look at the inoqula for errors around the detection of the bi-plates.Field service did not find anything that day and there were no issues in subsequent two days.On 04/jun/2020 the customer informed bd service desk that beads remained in the plates.Onsite investigation revealed that the lift/rotation functionality that rotates the plate for inoculation on both compartments, did not rotate fully.So, there was inoculation, but on the wrong section/divider of the compartments.The investigation continued on the scope of the samples/patients impacted.During an interview of the field service engineer involved, held on 10/jul/2020, the engineer was able to indicate that the customer narrowed down the scope to 6 plates incorrectly processed through the inoqula, by manually reprocessing 1000 samples/plates.The case has been escalated to the sustaining core team for further (technical) investigation.It has been ruled out that the plc settings are the cause since the issue was only limited to 6 samples and not all.Additional investigation in cooperation with the fse revealed the root cause: the bi-plate detection sensor is reacting too sensitive i.E.The sensor detects something which does not correspond to the bi-plate divider.Inoqula software version 20.3.104.860 is created and released to solve the issue related to incorrect detection of the bi-plate per change control# cc_2020_01296.This new inoqula version is part of icefall 3.2 release.To migrate to icefall 3.2 a customer has to be on icefall 2.3.1, then being updated to windows 10, before being able to migrate to icefall 3.2 per change control# cc_2020_01174.Since the occurrence of an incorrect bi-plate inoculation is rated low (based on the available pdv system) the sustaining core team has decided to maintain and continue the follow up of both changes and roll-out strategy.
Event or Problem Description
It was reported while using a bd kiestra¿ inoqula tla¿ to process patient samples a failure to inoculate specimen plates occurred for 6 samples.The laboratory initially interpreted the un-inoculated plates as negative, and reported results as such.Upon retesting the samples manually the laboratory confirmed the correct growth results were obtained.The issue resulted in a 2 day delay for the growth identification and corrected lab reports.No adverse medical impact was reported with regards to patients due to this issue.

• Brand Name: BD KIESTRA INOQULA+ TLA
• Common Device Name: MICROBIAL SPECIMEN INOCULATION
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 10228220
• Report Number: 1119779-2020-00203
• Device Sequence Number: 14251697
• Product Code: JTC
• UDI-Device Identifier: 00382904472139
• UDI-Public: 00382904472139
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (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): 09/22/2020

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: 447213
• Device Catalogue Number: 447213
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other