MAUDE Adverse Event Report: BD KIESTRA LAB AUTOMATION BD KIESTRA¿ INOQULA+¿ TLA; MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT

Catalog Number	447213
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Field correction initiated on 26 jul, 2019.Capa# (b)(4) has been opened to further investigate this issue.An anomaly was discovered in inoqula software (b)(4) that had the potential to cause a mismatch between a specimen and plate.The mismatch could happen when the following conditions occur together.Inoqula hardware is not operating, such as during a power outage.Pipette has already drawn a specimen waiting to be dispensed on a plate, and user selects the ¿reset¿ function from the system menu.An immediate update to the software was made and validated.All impacted customers were provided with the update and information on any mis-associated data in their system.This was done via a recall and an 806 form was submitted on 5 august, 2019.
Event or Problem Description
It was reported that while using a bd kiestra¿ inoqula+¿ tla an anomaly is present in inoqula/ inoqula+ software version (b)(4).During the investigation into this issue, through automated log-file analysis mis-associated plates/specimens were discovered.Customers have been informed about the events, including ids and accession ids that were mis-associated.

• Brand Name: BD KIESTRA¿ INOQULA+¿ TLA
• Common Device Name: MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT
• Manufacturer (Section D): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten
• MDR Report Key: 8936353
• Report Number: 3010141591-2019-00195
• Device Sequence Number: 16774461
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/22/2019

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: 447213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1119779-07/23/2019-004-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other