FDA Recall Terminated

MEDITECH Microbiology - Calculator/data processing module, for clinical use.

Recall: Z-1124-2014 · Initiated January 17, 2014

Recall

Recall Number
Z-1124-2014
Event Number
67458
Firm
Medical Information Technology, Inc.
FEI Number
3009404844
Product Code
JQP
Status
Terminated
Root Cause
Device Design
Initiated
January 17, 2014
Posted
March 3, 2014
Terminated
June 6, 2016
Address
7 Blue Hill River Rd, Canton, MA, 02021-1001

Description

MEDITECH Microbiology - Calculator/data processing module, for clinical use.

Reason

Potential for patient results being removed from LAB/EMR.

Action

Beginning on January 17, 2014 MEDITECH distributed a notification to MAGIC and Client Server customers who have the Microbiology product in TEST and/or LIVE only for the releases noted in this correction report. This notification was made via e-mailed task updates that can be printed by the customer. Task updates sent via e-mail are immediately transmitted to the customer. Instructions provided to customers: Task Description: CS LAB DTS 11696/MG LAB DTS 16703 - MIC: Inactive procedure prompt not displaying previous results. We are setting up this task to inform you of a potential patient safety issue that may result in patient results being removed from LAB/EMR. This task will continue to be updated to provide you with the status on this issue and details on the deployment of changes to address. This issue has been determined to impact both Client Server and MAGIC 5.6 and higher. Until the changes to address above are delivered, please refrain from inactivating procedure prompts in the MIC Procedure Dictionary. Although patient results are not permanently deleted from the record, because of the potential impact on a patient should this issue occur and go undetected, we felt it necessary to inform you of the issue. We strongly recommend delivery of the changes to address the issue. We have engaged all necessary resources within MEDITECH to identify and resolve this issue as expediently as possible. CS LAB DTS 11696 - MIC: Inactive procedure prompt not displaying previous results MG LAB DTS 16703 - MIC: Inactive procedure prompt not displaying previous results Inactivating Procedure Prompts in the MIC Procedure Dictionary causes data to be removed from existing specimens. These results are also removed from the EMR. However, once the prompts are re-activated, the results are again present on the specimens. We strongly recommend delivery of this change to your system to alleviate this potential patient safety concern. Please confirm via this task th

Distribution

Worldwide Distribution: US (nationwide) and to countries of: Canada, Ireland, and United Kingdom.

Quantity

737