MAUDE Adverse Event Report: SIEMENS SOARIAN; MDDS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 08/12/2014

Event Type  Injury  

Event Description

Severe hyperglycemia was present based on test results that became known when the patient was doing poorly, nearly 2 weeks after leaving the hospital observation unit.She was originally admitted for respiratory problems and was sent home with high glucose, tachycardia, but no pneumonia.From the high glucose, greater than 460 mg, the patient became dehydrated with worsening tachycardia, needing admission and fluid resuscitation.The results of the hyperglycemia were electronically sent to the ehr mdds, and were there without notice.Silent silos are common and results are often missed, which will ultimately result in medical catastrophe.

• Brand Name: SOARIAN
• Type of Device: MDDS
• Manufacturer (Section D): SIEMENS; malvern PA 19355
• MDR Report Key: 4046838
• MDR Text Key: 4809122
• Report Number: MW5037932
• 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: 08/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2014
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 76