MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500; CLINICAL CHEMISTRY ANALYZER,

Model Number DIMENSION VISTA 1500

Device Problem Mechanical Problem (1384)

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

Event Date 02/22/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The customer stated that quality control (qc) started running low since after the last service maintenance.A siemens customer service engineer (cse) was dispatched to the customer site.During troubleshooting the instrument, the cse performed mix test on sample arm and found poor precision.The cse replaced the sample mixer, reagent 3 (r3) probe and manifold.The cse reran mix test, and the mean was acceptable.The cse ran qc, resulting within specification.The cause for the discordant, falsely depressed (mg) result is due to a faulty r3 mixer.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely depressed magnesium (mg) result was obtained on a patient sample (sample id (b)(6) ) on a dimension vista 1500 instrument.The discordant result was reported to the physician(s).Two additional falsely depressed mg were obtained on the same dimension vista 1500 instrument.The discordant results were not reported to the physician(s).The samples were repeated on an alternate dimension vista instrument, resulting higher.The repeated results were reported to the physician(s) for all three patients.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed mg results.

• Brand Name: DIMENSION VISTA 1500
• 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: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6405510
• MDR Text Key: 70073215
• Report Number: 2517506-2017-00269
• Device Sequence Number: 0
• Product Code: JGJ
• 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: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION VISTA 1500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2014
• 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