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

Catalog Number 447213

Device Problem False Negative Result (1225)

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

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

Two patients were involved and this mdr is patient 1 of 2.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd kiestra¿ inoqula+¿ tla did not handle sample correctly.The inoqula+¿ pipet failed to inoculate two urine sample cultures resulting in a false negative being reported to the physician.Upon realization of the error, the customer proceeded to repeat all the negative urine cultures on bd kiestra¿ inoqula+¿ tla and also by manual inoculation.The initial result was then changed to positive e-coli but resulted in a two days delay in correct diagnosis.There was no indication of deterioration in patient condition.Patient 1 of 2.

Event Description

It was reported that bd kiestra¿ inoqula+¿ tla did not handle sample correctly.The inoqula+¿ pipet failed to inoculate two urine sample cultures resulting in a false negative being reported to the physician.Upon realization of the error, the customer proceeded to repeat all the negative urine cultures on bd kiestra¿ inoqula+¿ tla and also by manual inoculation.The initial result was then changed to positive e-coli but resulted in a two days delay in correct diagnosis.There was no indication of deterioration in patient condition.Patient 1of 2.

Manufacturer Narrative

Investigation summary: two urine samples (19ac520965 and 19ac522279) were not inoculated by the hamilton pipetting unit.The samples passed through the inoqula without giving an error message.Though the plates were not inoculated there is no indication that the pipetting unit had failed.The pipetting unit gives error messages for several possible functionality failures, however inoculation errors (drops actually released from the pipet tip) are not detected.Even with a correct working pipetting unit it is possible in rare cases that inoculation fails due to the sample material remaining in the pipet tip or the drop loosing too late.This may happen due to the nature, viscosity or substance of the sample material.The incorrect information, reported to the clinic (false negative), was corrected by the lab 2 days after the original results as a positive e-coli.The treatment of the patient is unknown, but there was also no indication given of deterioration in patient condition.The issue has been reported via a manufacturer's incident report to the national competent authority in sweden; medical products agency 'läkemedelsverket', reference number 897540.Because two patients were impacted two complaints were registered, one for each patient.These complaints are pr 897540 and pr 929382.Both complaints have been reported to fda.The issues have been reported via med watch, fda safety information and adverse event reporting program, to the fda, manufacturer report number respectively 3010141591-2019-00103 and 3010141591-2019-0010.The inoqula at this customer was installed in 2013, and models from that time were not equipped with a drop camera.The drop camera is a device that allows the customer to retrospectively check the inoculation of the plates.This inoqula was also not equipped with a pdv (positive drop verification) which instantly gives a message if the drop did not fall in the plate.The pdv is developed as an alternative for the drop camera and introduced under change control number 2016-0167.This device is developed to be implemented in the newer inoqula+.An upgrade kit for existing inoqula has become available only for inoqula from version 1.2 and newer.A pdv (positive drop verification) was installed on the customers inoqula to prevent further inoculation errors.The number of inoqula that have not been equipped with a drop camera or where no pdv was installed is not registered in servicemax but is estimated at maximum 30 units.Customers that have a drop camera built in on the inoqula often switch it off because the processing time increases if the drop camera is activated.Whenever the drop camera is switched off the customer relies on their expertise and experience to detect a missed inoculation.Also, many times more than one plate is inoculated.If no growth is seen on one plate while there is growth on the other plate, this indicates a possible inoculation failure.It is the customers¿ responsibility if they use the drop camera.A capa has been initiated to investigate the extent of the issue and take corrective and/or preventive measures.The reference is pr 994855 - inoqula - false negative urine sample.Conclusion: because there was no error message of the pipetting unit, there is no indication that the pipetting unit had failed.Due to the incidental nature of the error, no conclusive cause could be determined.

• Brand Name: BD KIESTRA¿ INOQULA+¿ TLA
• Type of Device: MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT
• Manufacturer (Section D): BD KIESTRA LAB AUTOMATION; 6 marconilaan; drachten
• MDR Report Key: 8580186
• MDR Text Key: 144101014
• Report Number: 3010141591-2019-00103
• Device Sequence Number: 1
• Product Code: JTC
• UDI-Device Identifier: 00382904472139
• UDI-Public: 00382904472139
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• 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
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention