MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500

Model Number DIMENSION VISTA® 500

Device Problem Mechanical Problem (1384)

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

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens technical support center (tsc) to report the discordant sodium result.The tsc took system into diagnostics mode and primed integrated multisensor technology (imt) probe, pump, and cleaner.The tsc auto-aligned imt and imt module, which passed without error.The tsc homed modules, exited diagnostics and reset the dimension vista.The tsc had replaced the v-lyte multi-sensor on the system followed by conditioning the sensor and repeated lytes quality control (qc) but it was out of range.The customer performed a dilution check and accepted the new correction factor.Qc was repeated and recovered within the customer's range.The cause of the discordant sodium result is unknown.This instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

A discordant, falsely high sodium result was obtained on one patient sample on a dimension vista 500 instrument.The initial result was reported to the physician(s).The same sample was repeated on an alternate instrument, and recovered lower.The corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely high sodium result.

• Brand Name: DIMENSION VISTA 500
• Type of Device: DIMENSION VISTA 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; registration # : 1226181; brookfield CT 06804
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6809902
• MDR Text Key: 83226046
• Report Number: 2517506-2017-00665
• Device Sequence Number: 0
• Product Code: JGS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION VISTA® 500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1