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

Catalog Number	447213
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	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 while using bd kiestra¿ inoqula+¿ tla, there was misassociation of one accession number.No patient impact reported.The following information was provided by the initial reporter: "inoqula scanning ascession number incorrectly.Scanning (b)(6) and showing (b)(6).There were no adverse effects or results from the miss scanning.The operator was able to scan the samples manually and prevent the sample from being processed.".
Additional Manufacturer Narrative
H.6.Investigation summary: this statement is to summarize the investigation of a complaint involving the bd kiestra inoqula tla.According to the information provided, the customer had reported that the inoqula 1 was scanning incorrectly.During the investigation, it was found that the inoqula scanner was not reading the accession number correctly.Instead of scanning (b)(6)., it was displaying (b)(6).The system support engineer (sse) logged into the system and restarted the kiestra lab automation (kla) services, and the customer restarted the laboratory information system (lis) services.The sse verified the lis communications, which were running without errors.Only this one sample was found to be scanned incorrectly.A root cause was not identified.There were no adverse effects or results from the scanning error.The operator was able to manually rescan the sample, which prevented the sample from being processed incorrectly.Following this action, no further issues were encountered.Based on the investigation, this case has been assessed as unconfirmed for a bd quality issue.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.Bd quality will continue to closely monitor for trends associated with this issue.
Event or Problem Description
It was reported that while using bd kiestra¿ inoqula+¿ tla, there was misassociation of one accession number.No patient impact reported.The following information was provided by the initial reporter: "inoqula scanning ascession number incorrectly.Scanning (b)(6).There were no adverse effects or results from the miss scanning.The operator was able to scan the samples manually and prevent the sample from being processed.".

• Brand Name: BD KIESTRA¿ INOQULA+¿ TLA
• Common Device Name: MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT
• Manufacturer (Section D): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten KY
• Manufacturer (Section G): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten KY
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17476505
• Report Number: 3010141591-2023-00004
• Device Sequence Number: 7416311
• Product Code: JTC
• UDI-Device Identifier: 00382904472139
• UDI-Public: 00382904472139
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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 Catalogue Number: 447213
• 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: 07/24/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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