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

Catalog Number	446973
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
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, there was a false negative of one sample.No patient impact reported.The following information was provided by the initial reporter: "10 ul of sample inoculated on drig: (b)(4), ss: (b)(6) and inoculation of a broth with 150 ul of sample.The cultures are negative on drig and ss but positive culture after enrichment.48h after fa the customer processed the sample manually and it went positive.
Event or Problem Description
It was reported that while using bd kiestra inoqula, there was a false negative of one sample.No patient impact reported.The following information was provided by the initial reporter: "10 ul of sample inoculated on drig (b)(6), (b)(6) and inoculation of a broth with 150 ul of sample.The cultures are negative on drig and ss but positive culture after enrichment.48h after fa the customer processed the sample manually and it went positive.
Additional Manufacturer Narrative
H.6.Investigation summary: this statement is to summarize the investigation of a complaint involving the bd kiestra inoqula.According to the information provided, an inconsistency in the growth results of a stool sample inoculated using inoqula fa was reported.During the investigation, a sample was applied to drig agar, ss agar, and a broth tube.Initial results showed no growth on the drig and ss agar after incubation.However, the broth tube, which was used to inoculate a new plate, showed positive growth after incubation.48 hours after the initial inoculation, the sample was manually retested, resulting in growth on both drig and ss agar.The root cause of the issue could not be definitively determined.The customer confirmed that they did not wish to pursue the matter further.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.H3 other text : see h.10.

• Brand Name: BD KIESTRA INOQULA
• 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: 17995089
• Report Number: 3010141591-2023-00005
• Device Sequence Number: 20521726
• Product Code: JTC
• UDI-Device Identifier: 00382904469733
• UDI-Public: (01)00382904469733
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• 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): 01/31/2024

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: 446973
• 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: 10/10/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2023
• 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