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

Model Number DIMENSION VISTA 500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/22/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer's site.The cse evaluated the instrument.The cse found the customer inadvertently ran a manual dilution factor of 3.The cause of the discordant, falsely elevated glucose result is due to user inadvertently running a manual dilution factor of 3.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely elevated glucose result was obtained on a patient sample on a dimension vista 500 instrument.The initial result was not released to the physician(s).The initial result showed an "e511: above reference range" error.The customer repeated the same sample on the same dimension vista instrument, resulting lower.The customer repeated the same sample on an alternate dimension vista instrument twice, resulting lower than the initial result.The customer reported out the repeat result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated glucose 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 number: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6411857
• MDR Text Key: 70178612
• Report Number: 2517506-2017-00267
• Device Sequence Number: 0
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• 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: 02/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2012
• 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