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

Catalog Number 447213

Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

Field correction initiated on 26 july, 2019.Capa# (b)(4) has been opened to further investigate this issue.An anomaly was discovered in inoqula software (b)(6) that had the potential to cause a mismatch between a specimen and plate.The mismatch could happen when the following conditions occur together.Inoqula hardware is not operating, such as during a power outage.Pipette has already drawn a specimen waiting to be dispensed on a plate, and user selects the ¿reset¿ function from the system menu.An immediate update to the software was made and validated.All impacted customers were provided with the update and information on any mis-associated data in their system.This was done via a recall and an 806 form was submitted on 5 august, 2019.

Event Description

It was reported that while using a bd kiestra¿ inoqula+¿ to process patient urine samples, the customer reported discrepancies in bacterial growth between the blood agar plates and the macconkry agar plates being used for culture after a power outage.Following the discovery of the discrepancy, instrument log files confirmed pipetting errors.During this review, the customer confirmed incorrect patient results were reported out.The initial reported result was k.Pneumoniae, e.Coli, and urethral flora, after replating the specimen, the result was amended to urethral flora.

• Brand Name: BD KIESTRA¿ INOQULA+¿ TLA
• Type of Device: 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8898850
• MDR Text Key: 155339730
• Report Number: 3010141591-2019-00140
• Device Sequence Number: 1
• Product Code: JTC
• UDI-Device Identifier: 00382904472139
• UDI-Public: 00382904472139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 447213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1119779-07/23/2019-004-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other