MAUDE Adverse Event Report: BD KIESTRA LAB AUTOMATION BD KIESTRA¿ IDENTIFA; MICROBIAL SPECIMEN INOCULATION/STREAKING/COLONY-PICKING INSTRUMENT IVD

Catalog Number 444063

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  malfunction  

Event Description

It was reported while using the bd kiestra¿ identifa there was crossover between patient sample wells on the target plate.This was visually observed during manual transfer of the target plate to another instrument.The healthcare worker did not use the target plate for microbial identification.There was no health impact or consequence reported.

Manufacturer Narrative

D2b.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: qqv the information for the additional 510k is as follows: g5.Pma / 510(k)#: k222563 e1.Initial reporter address: (b)(6).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD KIESTRA¿ IDENTIFA
• Type of Device: MICROBIAL SPECIMEN INOCULATION/STREAKING/COLONY-PICKING INSTRUMENT IVD
• Manufacturer (Section D): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten KY
• Manufacturer (Section G): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten KY
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18799026
• MDR Text Key: 336530066
• Report Number: 3010141591-2024-00003
• Device Sequence Number: 1
• Product Code: QBN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2024

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
• Device Operator: Other
• Device Catalogue Number: 444063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1