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 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The ccc reviewed the data supplied.The ccc found the customer's quality control (qc) was out of range at the time of the event.The customer replaced the v-lyte diluent.The customer ran qc, resulting in range.The customer repeated the same samples, resulting within the expected clinical range.A siemens headquarters support center (hsc) reviewed the event.Hsc confirmed the reported issue.The cause of the discordant, falsely elevated sodium result is due to insufficient v-lyte diluent to perform the integrated multisensor technology dilution for patient samples as a result of the v-lyte diluent bottle not being properly seated by the user.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely elevated sodium result was obtained on a patient sample on a dimension vista 500 instrument.The initial result was released to the physician(s).The customer repeated the same sample on an alternate dimension vista instrument, resulting lower.The customer issued a corrected report with the alternate instrument result.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated sodium 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: 6552481
• MDR Text Key: 74756246
• Report Number: 2517506-2017-00347
• 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: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• 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: 04/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2016
• 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