MAUDE Adverse Event Report: ALLSCRIPTS ALLSCRIPTS; CLINICAL INFO SYSTEM

Device Problem Device Markings/Labelling Problem (2911)

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

Event Type  Other  

Event Description

Our clinical information system (cpoe, emar, bcma) is xxxx xxxxxx xxxxxx from allscripts.We do not have control of the formatting of their labels.Their canned format does not include a leading zero in front of doses less than one.We had one near miss with a levothyroxine injection.We reported this to allscripts and they have not embraced it as a priority.I will send an example of a penicillin g potassium label in a separate email.Patient counseling provided: unknown.Relevant materials provided: none.(b)(6).

• Brand Name: ALLSCRIPTS
• Type of Device: CLINICAL INFO SYSTEM
• Manufacturer (Section D): ALLSCRIPTS
• MDR Report Key: 4713912
• MDR Text Key: 5660960
• Report Number: MW5042170
• Device Sequence Number: 1
• Product Code: JQP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2015

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2015
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE SODIUM