MAUDE Adverse Event Report: BD KIESTRA LAB AUTOMATION BD KIESTRA¿ IDENTIFA; SEE H11

Catalog Number	444063
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	11/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2.Additional medical device type: qqv.Common device name: automated system for sample preparation and identification of microorganisms from cultured isolates by mass spectrometry g5.Additional 510k: k222563.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that four specimens that were prepared on the bd kiestra¿ identifa gave false identification results: enterococci was identified as staphylococcus.Enterococci was identified as ecoli.Proteus was identified as staph.Hemolyticus.E.Coli was identified as str.Constellatus there was no report of patient impact.
Additional Manufacturer Narrative
H.6.Investigation summary: this statement is to summarize the investigation of a complaint involving the bd kiestra identifa.According to the information provided, the customer reported that the maldi system gave incorrect bacterial identifications after the target plate was removed from the identifa system.These misidentifications were confirmed by comparing the maldi results with manual verification using the vitek system, which provided the correct bacterial strains.During the investigation, the field service engineer (fse) confirmed that the maldi system had previously produced incorrect results for several isolates.The fse performed maintenance on the device.Upon re-evaluation, the issue could not be reproduced, and no new occurrences were reported.Based on this, the case was closed.Following this action, no further issues were encountered.Based on the investigation, this case has been assessed as confirmed 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.The results of this evaluation have not identified any new hazards, new risks, or specific trends.Bd quality will continue to closely monitor trends associated with this issue.
Event or Problem Description
It was reported that four specimens that were prepared on the bd kiestra¿ identifa gave false identification results: enterococci was identified as staphylococcus enterococci was identified as ecoli proteus was identified as staph.Hemolyticus e.Coli was identified as str.Constellatus there was no report of patient impact.

• Brand Name: BD KIESTRA¿ IDENTIFA
• Common Device Name: SEE H11
• Manufacturer (Section D): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten ; NL
• Manufacturer (Section G): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten ; NL
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20887263
• Report Number: 3010141591-2024-00008
• Device Sequence Number: 18403062
• Product Code: QBN
• UDI-Device Identifier: 00382904440633
• UDI-Public: (01)00382904440633(11)210414
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K191964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 444063
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2021
• 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