MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500

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 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report the discordant sodium result.Quality control (qc) was within range.The customer replaced v-lyte cartridge lot 7dd898 by lot 7dd896 and will monitor sodium performance.The cause of the discordant sodium result is unknown.Siemens is investigating the issue.

Event Description

Discordant falsely high sodium results were obtained on two patient samples on a dimension vista 500 instrument.The initial results were not reported to the physician(s).The same samples were repeated on an alternate instrument, and recovered lower.The repeat results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely high sodium results.

Manufacturer Narrative

Additional information (10/25/2017): a siemens headquarter support center (hsc) specialist reviewed the instrument data which indicated an obstruction of fluid flow in the integrated multisensor technology (imt) system.Clog detected errors were observed.Poor sample quality and the presence of gel, fibrin, and/or cellular material in sample(s) causing a clog cannot be ruled out as a contributing factor.Water contamination may have impacted the results but cannot be confirmed as the cause.No product problem has been identified.The cause of the discordant sodium results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: DIMENSION VISTA 500
• Type of Device: DIMENSION VISTA 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; registration # : 1226181; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6903908
• MDR Text Key: 89487590
• Report Number: 2517506-2017-00739
• Device Sequence Number: 0
• Product Code: JGS
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• 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: 10/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2009
• 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