MAUDE Adverse Event Report: ALLSCRIPTS SUNRISE EHR; EHR/MDDS

Device Problems False Reading From Device Non-Compliance (1228); High Test Results (2457)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/01/2014

Event Type  Injury  

Event Description

The pt with congestive heart failure with arrhythmias went for eval at er after ingesting excess diuretics.The doctor in the er was of the impression that the potassium was normal.The ehr mdds did not adequately disclose that the sample of blood was hemolyzed, falsely elevating the potassium, providing the illusion it was normal, when it was severely low.There was a tiny asterisk in the corner of the mdds grid, requiring a click to find out that the result was spurious.

• Brand Name: SUNRISE EHR
• Type of Device: EHR/MDDS
• Manufacturer (Section D): ALLSCRIPTS; raleigh 27615
• MDR Report Key: 3999615
• MDR Text Key: 4954331
• Report Number: MW5037670
• Device Sequence Number: 1
• Product Code: LNX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 93