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

Model Number	447213
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while testing with the bd kiestra¿ inoqula+¿ tla, false positive results were obtained.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that a new organism is being introduced in the blood culture.Gram negative rods appearing on blood culture when it should not be.Patient results are incorrect.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6 investigation summary customer reported new organism being introduced in blood culture.This was in relation to bd kiestra inoqula tla (material: 447213, serial number: (b)(6).).Bd technical service conducted an investigation.Reada overview logs were reviewed.It was determined that culture was set up fully automated and did not leave the reada compact until after first and second images where taken.No source of contamination could be tracked to bd kiestra device.If there was a contamination of beads, pipets, or spreader on inoqula then the contamination would be present on multiple plates/cultures.Results of the investigation were shared with the customer.Customer was requested to report any additional potential contaminations.After two days no additional reports were received.Complaint could not be confirmed.No device issues found.A review of risk management documentation indicates that the potential risk of the reported failure mode was appropriately assessed as s3 via baltrm-inoqula-aph rev.14, id 3.03.
Event or Problem Description
It was reported that while testing with the bd kiestra¿ inoqula+¿ tla, false positive results were obtained.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that a new organism is being introduced in the blood culture.Gram negative rods appearing on blood culture when it should not be - patient results are incorrect.

• Brand Name: BD KIESTRA¿ INOQULA+¿ TLA
• Common Device Name: MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT
• Manufacturer (Section D): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten
• Manufacturer (Section G): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13607733
• Report Number: 3010141591-2022-00001
• Device Sequence Number: 1969779
• Product Code: JTC
• UDI-Device Identifier: 00382904472139
• UDI-Public: 00382904472139
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2018
• 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