MAUDE Adverse Event Report: SIEMEN HEALTHCARE DIAGNOSTICS INC. SIEMENS VISTA 1500

Model Number 630414949741

Device Problem Complete Blockage (1094)

Patient Problem No Code Available (3191)

Event Date 11/03/2016

Event Type  Injury  

Event Description

The vista lab machine was resulting sodium and potassium levels as low.There was a 20 unit dip in results.The lab tech had noticed some trending of low lab levels and reran the results.He reported these to the physicians.Siemen was contacted and came to service the machine.They found that there was a int clogged drain.This was fixed and then was functioning properly.All lab results that erroneously reported were caught with the exception of this pt.The erroneous results had been reported to the doctor earlier during the day and when the erroneously results were discovered they were reran around 1700.The test resulted out after clinic hours and the lab department attempted to reach the doctor but were unsuccessful.On (b)(6) 2016, risk was notified that the pt had been admitted the night before for low sodium and potassium levels and had been treated for these results.The pt was discharged home on (b)(6) 2016.

• Brand Name: SIEMENS VISTA 1500
• Type of Device: VISTA 1500
• Manufacturer (Section D): SIEMEN HEALTHCARE DIAGNOSTICS INC. ; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 6145815
• MDR Text Key: 61512074
• Report Number: 6145815
• Device Sequence Number: 1
• Product Code: JHY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 630414949741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2016
• Distributor Facility Aware Date: 11/03/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR