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 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens technical business lead (tbl) remotely reviewed the error log and found no issue with the integrated multi-sensor technology (imt) system.The tbl also noticed that the customer had recently loaded fresh quality control (qc) solution and ran it from a cup and from a vial.The customer had also replaced the standard a solution, after which quick check on imt module, was run and passed.The customer aligned the imt and imt probe.A siemens customer service engineer was dispatched to the customer site.While inspecting the instrument, the cse found microbubbles in the a line.The cse replaced the pump tubing and consumables.The cse reran quality control (qc), resulting within acceptable range.The cause of the discordant, falsely elevated na result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely elevated sodium (na) result was obtained on a patient sample on a dimension vista 500 instrument.The discordant result was reported to the physician(s) who questioned it.The sample was repeated on an alternate dimension vista instrument, resulting lower and as expected.The alternate instrument result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated na result.

• 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: 6880693
• MDR Text Key: 87215211
• Report Number: 2517506-2017-00704
• 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: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• 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: 08/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/18/2014
• 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