MAUDE Adverse Event Report: CERNER CORPORATION CERNER AUTOMATED ALIQUOTTER; SOFTWARE

Model Number AA

Device Problem Failure to Align (2522)

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

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

Cerner has made changes to the barcode reader to narrow the scanner beam and realign the scanner to the proper angle.Cerner is implementing a further hardware modification to disallow the barcode reader to be out of alignment.Cerner is in contact with the client regarding the resolution of the issue and provided formal notification of the issue on august 18, 2016.The other client with the same version of the device was notified of the issue on august 18, 2016.Cerner corporation will provide a follow-up report when the modification is fully implemented.

Event Description

This report documents information related to an issue reported in association with functionality included in cerner automated aliquotter.The issue involves functionality of the cerner automated aliquotter.The issue occurs when a primary specimen moves into the secondary lane in the aliquotter and the automated aliquotter barcode scanner is misaligned.When this occurs, the barcode reader reads the incorrect tube and not the tube the system was attempting to aliquot into.This could lead to a specimen being aliquoted into a tube that contains the specimen from a different patient.Cerner has received a report of one occurrence of this issue but there was no patient care incident as the specimens were removed from the line.

Manufacturer Narrative

Cerner has made changes to the barcode reader to narrow the scanner beam and realign the scanner to the proper angle.Cerner has implemented a hardware modification at the reporting client site to disallow the barcode reader to be out of alignment.This was completed on august 24, 2017.The other client with the same version of the device was notified of the issue on august 18, 2016.The hardware modification was implemented at this client site on january 25, 2017.Cerner corporation considers the issue resolved and no further narrative is required for follow-up.

Event Description

This report documents information related to an issue reported in association with functionality included in cerner automated aliquotter¿.The issue involves functionality of the cerner automated aliquotter¿.The issue occurs when a primary specimen moves into the secondary lane in the aliquoter and the automated aliquoter barcode scanner is misaligned.When this occurs, the barcode reader reads the incorrect tube and not the tube the system was attempting to aliquot into.This could lead to a specimen being aliquoted into a tube that contains the specimen from a different patient.Cerner has received a report of one occurrence of this issue but there was no patient care incident as the specimens were removed from the line.

• Brand Name: CERNER AUTOMATED ALIQUOTTER
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rockcreek parkway; kansas city MO 64117
• Manufacturer (Section G): CERNER CORPORATION; 2800 rockcreek parkway; kansas city MO 64117
• Manufacturer Contact: shelley looby ; 2800 rockcreek parkway; kansas city, MO 64117 ; 8162011368
• MDR Report Key: 5915946
• MDR Text Key: 54295062
• Report Number: 1931259-2016-00012
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AA
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1