MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500; CLINICAL CHEMISTRY ANALYZER,

Model Number DIMENSION VISTA 500

Device Problem Mechanical Problem (1384)

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

Event Date 04/22/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After analyzing the instrument, the cse removed the integrated multi-sensor technology (imt) module and replaced it with a new one.The cse replaced the imt rotary valve and motor.The cse power flushed the imt system and realigned it.The cse replaced the imt probe and realigned it.The cse performed quick check, which passed and ran imt quality control (qc), resulting within acceptable ranges.The cse ran precision and patient comparison testing, resulting satisfactory.A regional support center (rsc) specialist reviewed the instrument data with the technical applications specialist (tas) which indicated poor sample handling.The rsc specialist instructed the tas to discuss with the customer the use of proper sample handling techniques to minimize potential sample integrity issues.The cause of the discordant, falsely elevated na results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely elevated sodium (na) results were obtained on patient samples on a dimension vista 500 instrument.The discordant results were reported to the physician(s), who questioned them.New samples obtained from the patients were tested on an alternate dimension vista instrument, resulting lower.The new sample results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated na results.

• Brand Name: DIMENSION VISTA 500
• Type of Device: CLINICAL CHEMISTRY ANALYZER,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; registration #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6575551
• MDR Text Key: 75522036
• Report Number: 2517506-2017-00487
• 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: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• 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: 04/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2016
• 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