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 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The ccc specialist instructed the customer to clean the aliquot probe and drain, the integrated multi-sensor technology (imt) probe and perform alignments.The customer did not perform troubleshooting as indicated by ccc.The customer instead, ran precision on patient samples, which resulted satisfactory.The customer determined the cause of the falsely low cre2 result was associated with sample integrity.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely low urine creatinine (cre2) result was obtained on one patient sample on a dimension vista 500 instrument.The discordant result was not reported to the physician(s).The sample was repeated twice on the same dimension vista instrument, resulting higher than the initial result.The second repeat result was obtained at the end of the reagent flex well.The first repeat result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low urine creatinine (cre2) 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: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6453290
• MDR Text Key: 71707249
• Report Number: 2517506-2017-00327
• Device Sequence Number: 0
• Product Code: CGX
• 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: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• 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: 03/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2015
• 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